BD Luer-Lok 309646Recalls & reported problems

Summary

The FDA's MAUDE database contains 311 adverse event reports that list this exact device (DI 30382903096467), received between Nov 1, 2017 and Sep 25, 2026 — classified as 2 injuries, 309 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (76 reports).

10 other recalls cover devices cleared under the same FDA submission (K110771); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 311 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899355 ↗
• MalfunctionSep 18, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828915 ↗
• MalfunctionSep 18, 2026Wrong Label

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827366 ↗
• MalfunctionSep 15, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780212 ↗
• MalfunctionSep 15, 2026Contamination /Decontamination Problem

  It was reported that BD SYRINGE 5ML LL SP125 contained foreign matter.complaint via email. Manufactured product had two particulates found. Probablecause cellulose fiber in syringes used.On (b)(6)2026, during visual inspection of the final product bags, MFGoperator identified a particulate in product bag 2 and QA Ops Specialistidentified a particulate in product bag 1. The particulate in Bag 1 wasnot able to be identified using the library. The particulate in Bag 2 wasdetermined to be an intrinsic particle. Both bags were rejected.Per the investigation - The 6M Root Cause Analysis determinedMaterials to be the primary root cause of both of these particulates. Theparticle in Bag 1 was determined to have potentially interacted with theHuman Male AB Serum (hABS) used. The particle in Bag 2 wasidentified to be found in syringes during a rinse study performed byElevateBio. The textile cellulose fiber in Bag 2 is considered a typicalextrinsic particulate as it can be attributed to the vendor manufacturingprocess, but is not a part of the material of construction of the rawmaterial itself.Sinking white and black particulates are not expected as a part of thefinal DP.The black particulate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775091 ↗
• MalfunctionJul 28, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059449 ↗
• MalfunctionMay 15, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 5ML LL SP125 CONTAINED FOREIGN MATTER. COMPLAINT VIA EMAIL. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC X AND X ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO. ITEM: 309646. QUANTITY AFFECTED: 1 EA SERIAL/LOT NUMBER: (B)(6). PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: ISSUE: STICKY RESIDUE ON THE SYRINGE. CUSTOMER DISPOSITION REQUEST: REPLACEMENT. CUSTOMER CONTACT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191372 ↗
• MalfunctionMay 8, 2026Leak/Splash

  IT WAS REPORTED THAT BD SYRINGE 5ML LL HAD LEAKAGE. INCIDENT OR PROBLEM INFORMATION REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2026 TYPE OF INCIDENT/PROBLEM: A2. FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE). LEVEL OF HARM: NO APPARENT HARM - REACHED THE PATIENT/PERSON - INCONVENIENT OPTIONAL REPORT TO: YES. INCIDENT DETAILS: WHEN PUSHING ROCURONIUM, THE DRUG LEAKED OUT OF THE SIDE OF THE SYRINGE. DEVICE INFORMATION DEVICE NAME/DESCRIPTION: SYRINGE LUER LOCK TIP 5ML. MANUFACTURER MANUFACTURER CODE/MODEL: 309646 SERIAL OR LOT NUMBER: (B)(6) EXPIRY DATE: 2030-11-30. SUPPLIER: SUPPLIER/CATALOGUE NUMBER: 308-309646 IS THE DEVICE RETAINED? YES NUMBER OF DEVICES: 2 WIPED, CONTAINED, LABELLED? WIPED, DOUBLED BAGGED (IF CONSUMABLE), AND LABELLED AS PER INSTRUCTIONS. INVESTIGATION REQUEST EXPECTED TYPE OF INVESTIGATION: ACTUAL DEVICE TESTED; LOT REVIEW ¿ ARE YOU NOTICING A TREND WITH CRACKS/LEAKING FROM THE SYRINGE WHERE THE MEDICATION ROCURONIUM IS IDENTIFIED? E-MAIL ADDRESS FOR PERSON HOLDING DEVICE: SITE SHIPPING ADDRESS: CLINICAL CONTACT INFORMATION. PRIMARY CLINICAL CONTACT (CC ON FINAL REPORT): MANAGER (CC ON FINAL REPORT): FILING REFERENCE ID: (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128085 ↗
• MalfunctionApr 17, 2026Labelling, Instructions for Use or Training Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916207 ↗
• MalfunctionMar 6, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 5ML LL SP125 CONTAINED FOREIGN MATTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. OUR MONROE TEAM FOUND DIRTY FLAKES INSIDE A 5 ML SYRINGE #309646 LOT #5363819. I HAVE THE SAMPLE AT MY DESK TO RETURN WE HAVE GONE THROUGH OUR REMAINING STOCK AND HAVEN'T NOT FOUND ANY OTHER EXAMPLES. 17 FEB 2026: DATE OF INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536694 ↗
• MalfunctionDec 17, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309646. BATCH # UNKNOWN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I'D LIKE TO SUBMIT A CONCERN ABOUT A SYRINGE MALFUNCTION. BD SYRINGE 5 ML LUER LOK TIP SYRINGE PRODUCT # 309646. LOT 515404. EXP 04/30/30. THERE WAS A CRACK IN THE SYRINGE. WHEN IT WAS USED, MEDICATION SPRAYED OUT OF THE SIDE OF THE SYRINGE. ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF INCIDENT IN THIS FORMAT MM-DD-YYYY? (B)(6) 2025. 2. IS THERE A PHOTO/VIDEO OR PHYSICAL SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? N/A. 3. IT APPEARS THAT THE PROVIDED LOT NUMBER [515404] MAY CONTAIN A TYPO. COULD YOU PLEASE VERIFY AND CONFIRM THE CORRECT LOT NUMBER? I'VE CONFIRMED AND THIS IS THE LOT NUMBER THAT WAS PROVIDED IN THE INCIDENT REPORT. 1. WHICH PART OF THE SYRINGE WAS CRACK. TOP OF THE BARREL/BOTTOM OF THE LUER LOCK 2. PLEASE CONFIRM ON ANY HARM OR PATIENT IMPACT. DRUG SQUIRTED OUT SIDEWAYS AND INTO TECHNICIAN'S EYE - NO LASTING HARM. 3. KINDLY PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835258 ↗
• MalfunctionDec 8, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 BARREL /FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT REFERENCE #: (B)(4). HOSPITAL COMPLAINT REFERENCE #: (B)(4). CORRESPONDENCE LANGUAGE: FRENCH. CAT# OF PRODUCT BEING COMPLAINED: BD309646. DESCRIPTION OF PRODUCT: SYRINGE ONLY LUER-LOK TIP 5CC ST 125EA/BX 4BX/CA. LOT OR S/N: (B)(6). COMPLAINT CATEGORY: STERILITY COMPROMISED / SEAL INTEGRITY. REPORTABLE: NO. INCIDENT DATE: (B)(6) 1980. HOSPITAL COMPLAINT REFERENCE #: (B)(4). DETAILS OF COMPLAINT (REPORTED ISSUE): PER CUSTOMER, PARTIALLY TRANSLATED, DURING INJECTION, A SIGNIFICANT LEAK OF FLUID WAS OBSERVED, ORIGINATING FROM SMALL HOLES ON THE SIDE OF THE SYRINGE. CONSEQUENTLY, THE STERILITY OF THE PRODUCT IS COMPROMISED. ADDITIONAL INFORMATION WILL BE SENT VIA SEPARATE EMAIL. PLEASE NOTE: INCIDENT DATE, QUANTITY OF PRODUCT AFFECTED & SAMPLE AVAILABILITY IS UNKNOWN. COMPLAINT NOTICED: DURING / AFTER USE. PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: PATIENT INJURY: NO. HAVE THEY BEEN INFORMED? UNKNOWN. QTY AFFECTED: (B)(4) EACH. SAMPLES AVAILABLE? NO. IS CUSTOMER REQUESTING AN RGA?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23738790 ↗
• MalfunctionNov 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309646. BATCH # 5204460. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. SITUATION: ISSUE: THE REPORTING CAREGIVER POPPED THE TOPS OFF BOTH THE STERILE WATER AND AMPICILLIN VIALS. CLEANED THE TOPS WITH AN ALCOHOL SWAB AND PEELED OPEN THE 5ML SYRINGE PACKAGE (NORMAL- SHE DID NOT BREAK THE PACKAGING OR CAUSE DAMAGE IN ANY WAY) AND THEN A 20G NEEDLE, CONNECTED THEM AND TOOK OFF THE NEEDLE CAP. PUNCTURED THE STERILE WATER, DRAWING UP 5ML AND TRANSFERRING THE 5 ML OF WATER TO THE AMPICILLIN. WHILE INJECTING THE WATER IN, SHE NOTED A BLACK PARTICLE IN THE SYRINGE. SHE THEN STOPPED AND PULLED OUT THE NEEDLE. UPON FURTHER INSPECTION, SHE NOTED THE BLACK PARTICLE WAS MOBILE AND NOT JUST MARKINGS ON THE EXTERIOR OF THE SYRINGE. SHE THEN PACKAGED UP ALL OF THE SUPPLIES AND PLACED THEM IN A BIOHAZARD BAG FOR REPORTING AND DID NOT REMOVE THE PARTICLE. BACKGROUND: EVENT DATE: 10/15/2025. ITEM DESCRIPTION: SYRINGE 5ML L/L. INTERMOUNTAIN HEALTH #: 93055444. MFG #: 309646. LOT #: 5204460. SAMPLE AVAILABLE: YES (IF SAMPLE IS AVAILABLE AND WOULD LIKE IT SENT FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584802 ↗
• MalfunctionOct 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309646. LOT # 5112794. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PARTICULATE OBSERVED AT SITE OF CARE XXXX PER SCAR - 00051 ATTACHMENT 1 CHARACTERIZATION REPORT THE COMBINED MORPHOLOGY. CHEMICAL (FT-IR) AND ELEMENTAL (EDS) DATA INDICATE THAT THE FREE-FLOATING PARTICULATE OBSERVED INSIDE OF THE BREYANZI VIAL CD8 HAS CONSISTENCY WITH A POLYACRYLATE-BASED MATERIAL. WHEN DISCOVERED ON (B)(6) 2025. WEIGHT LIMITED TO ONE SYRINGE OF LOT 5112794. MATERIAL NAME - SYRINGE DISPOSABLE LUER-LOK 5ML. VENDOR MANUFACTURING LOT 5112794. PER CUSTOMER. THE DEFECT IN THIS EVENT IS FROM A FREE-FLOATING PARTICULATE WHICH WAS OBSERVED INSIDE A BREYANZI CDB CELLSEAL VIAL. THIS PARTICULATE WAS OBSERVED INSIDE THE CD8 CELLSEAL VIAL AT THE SITE OF CARE, WHICH IS DOWNSTREAM OF THE USE OF THE 5ML SYRINGE. THE AFFECTED PRODUCT WAS NOT ADMINISTERED TO THE PATIENT THE PARTICULATE WAS NOTICED AT THE SITE OF CARE DURING THAWING, PRIOR TO INOCULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417735 ↗
• MalfunctionOct 21, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309646. BATCH#: 5029101. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON (B)(6) 2025, WE ENCOUNTERED A NEW INCIDENT INVOLVING PRODUCT 309646, LOT 5029101, WITH AN EXPIRATION DATE OF DECEMBER 31, 2029. TWO PACKAGES OF 5 ML SYRINGES WERE OPENED, AND BOTH WERE FOUND TO BE DEFECTIVE: SYRINGE #1: THE NURSE NOTICED THAT THE SYRINGE WAS WET. WHEN SHE LIGHTLY PRESSED THE PLUNGER, THE MEDICATION SPLASHED AND REACHED HER EYE. SYRINGE #2: THE NURSE OBSERVED A PERSISTENT LEAK. UPON CLOSER INSPECTION, SHE NOTICED A CRACK IN THE PLUNGER AND A DEPOSIT OF FLOATING BROWN SEDIMENT INSIDE THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352261 ↗
• MalfunctionOct 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309646, BATCH#: 5029101. RCC RECEIVED A COMPLAINT VIA EMAIL. ON (B)(6) 2025, WE ENCOUNTERED A NEW INCIDENT INVOLVING PRODUCT 309646, LOT: 5029101, WITH AN EXPIRATION DATE OF DECEMBER 31, 2029. TWO PACKAGES OF 5 ML SYRINGES WERE OPENED, AND BOTH WERE FOUND TO BE DEFECTIVE: SYRINGE #1: THE NURSE NOTICED THAT THE SYRINGE WAS WET. WHEN SHE LIGHTLY PRESSED THE PLUNGER, THE MEDICATION SPLASHED AND REACHED HER EYE. SYRINGE #2: THE NURSE OBSERVED A PERSISTENT LEAK. UPON CLOSER INSPECTION, SHE NOTICED A CRACK IN THE PLUNGER AND A DEPOSIT OF FLOATING BROWN SEDIMENT INSIDE THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352135 ↗
• MalfunctionOct 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309646. BATCH#: 5029101. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON (B)(6) 2025, WE ENCOUNTERED A NEW INCIDENT INVOLVING PRODUCT 309646, LOT 5029101, WITH AN EXPIRATION DATE OF DECEMBER 31, 2029. TWO PACKAGES OF 5 ML SYRINGES WERE OPENED, AND BOTH WERE FOUND TO BE DEFECTIVE: SYRINGE #1: THE NURSE NOTICED THAT THE SYRINGE WAS WET. WHEN SHE LIGHTLY PRESSED THE PLUNGER, THE MEDICATION SPLASHED AND REACHED HER EYE. SYRINGE #2: THE NURSE OBSERVED A PERSISTENT LEAK. UPON CLOSER INSPECTION, SHE NOTICED A CRACK IN THE PLUNGER AND A DEPOSIT OF FLOATING BROWN SEDIMENT INSIDE THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352132 ↗
• MalfunctionOct 21, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD VISIBLE DROPLETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309646, BATCH#: 5029101. RCC RECEIVED A COMPLAINT VIA EMAIL. ON (B)(6) 2025, WE ENCOUNTERED A NEW INCIDENT INVOLVING PRODUCT: 309646, LOT: 5029101, WITH AN EXPIRATION DATE OF DECEMBER 31, 2029. TWO PACKAGES OF 5 ML SYRINGES WERE OPENED, AND BOTH WERE FOUND TO BE DEFECTIVE: SYRINGE #1: THE NURSE NOTICED THAT THE SYRINGE WAS WET. WHEN SHE LIGHTLY PRESSED THE PLUNGER, THE MEDICATION SPLASHED AND REACHED HER EYE. SYRINGE #2: THE NURSE OBSERVED A PERSISTENT LEAK. UPON CLOSER INSPECTION, SHE NOTICED A CRACK IN THE PLUNGER AND A DEPOSIT OF FLOATING BROWN SEDIMENT INSIDE THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352131 ↗
• MalfunctionOct 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309646 BATCH#: 5043409 IT WAS REPORTED BY THE CUSTOMER THAT SYRINGE HAD DIRT/DEBRIS ON IT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 5ML STERILE SYRINGE OPENED BY PROVIDER PRIOR TO ADMINISTERING INJECTION. PROVIDER NOTED THAT SYRINGE HAD DIRT/DEBRIS ON IT. ADDITIONAL INFORMATION PROVIDED ON 09/30/2025: "DEBRIS WAS LOCATED IN THE BARREL OF THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341584 ↗
• MalfunctionOct 16, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD SYRINGE 5 ML LL SP125 BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 309646; BATCH#: 5029101. IT WAS REPORTED BY A CUSTOMER THAT THEY OPENED TWO PACKAGES OF 5 ML SYRINGES. ONE SYRINGE WAS NOTED THAT THE SYRINGE WAS WET. WHEN PRESSING LIGHTLY ON THE PLUNGER, THE MEDICATION SPLASHED AND SPLASHED INTO HER EYE AND ANOTHER SYRINGE WAS NOTICED A PERSISTENT LEAK. UPON CLOSER INSPECTION, SHE OBSERVED A CRACK IN THE PLUNGER, AS WELL AS A DEPOSIT OF FLOATING BROWN SEDIMENT INSIDE THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON 09/30/2025, WE ENCOUNTERED A NEW INCIDENT WITH PRODUCT 309646, BATCH 5029101, WITH AN EXPIRATION DATE OF 12/31/2029. TWO PACKAGES OF 5 ML SYRINGES WERE OPENED, AND THEY WERE FOUND TO BE DEFECTIVE: SYRINGE #1: THE NURSE NOTED THAT THE SYRINGE WAS WET. WHEN PRESSING LIGHTLY ON THE PLUNGER, THE MEDICATION SPLASHED AND SPLASHED INTO HER EYE. SYRINGE #2: THE NURSE NOTICED A PERSISTENT LEAK. UPON CLOSER INSPECTION, SHE OBSERVED A CRACK IN THE PLUNGER, AS WELL AS A DEPOSIT OF FLOATING BROWN SEDIMENT INSIDE THE SYRINGE. ATTACHED, YOU WILL FIND PHOTOS ILLUSTRATING THESE ANO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319022 ↗
• MalfunctionOct 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5 ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 309646; BATCH#: 5029101. IT WAS REPORTED BY A CUSTOMER THAT THEY OPENED TWO PACKAGES OF 5 ML SYRINGES. ONE SYRINGE WAS NOTED THAT THE SYRINGE WAS WET. WHEN PRESSING LIGHTLY ON THE PLUNGER, THE MEDICATION SPLASHED AND SPLASHED INTO HER EYE AND ANOTHER SYRINGE WAS NOTICED A PERSISTENT LEAK. UPON CLOSER INSPECTION, SHE OBSERVED A CRACK IN THE PLUNGER, AS WELL AS A DEPOSIT OF FLOATING BROWN SEDIMENT INSIDE THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON 09/30/2025, WE ENCOUNTERED A NEW INCIDENT WITH PRODUCT 309646, BATCH 5029101, WITH AN EXPIRATION DATE OF 12/31/2029. TWO PACKAGES OF 5 ML SYRINGES WERE OPENED, AND THEY WERE FOUND TO BE DEFECTIVE: SYRINGE #1: THE NURSE NOTED THAT THE SYRINGE WAS WET. WHEN PRESSING LIGHTLY ON THE PLUNGER, THE MEDICATION SPLASHED AND SPLASHED INTO HER EYE. SYRINGE #2: THE NURSE NOTICED A PERSISTENT LEAK. UPON CLOSER INSPECTION, SHE OBSERVED A CRACK IN THE PLUNGER, AS WELL AS A DEPOSIT OF FLOATING BROWN SEDIMENT INSIDE THE SYRINGE. ATTACHED, YOU WILL FIND PHOTOS ILLUSTRATING THESE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319020 ↗
• MalfunctionOct 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5 ML LL SP125 HAD VISIBLE DROPLETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 309646; BATCH #: 5029101. IT WAS REPORTED BY A CUSTOMER THAT THEY OPENED TWO PACKAGES OF 5 ML SYRINGES. ONE SYRINGE WAS NOTED THAT THE SYRINGE WAS WET. WHEN PRESSING LIGHTLY ON THE PLUNGER, THE MEDICATION SPLASHED AND SPLASHED INTO HER EYE AND ANOTHER SYRINGE WAS NOTICED A PERSISTENT LEAK. UPON CLOSER INSPECTION, SHE OBSERVED A CRACK IN THE PLUNGER, AS WELL AS A DEPOSIT OF FLOATING BROWN SEDIMENT INSIDE THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON 09/30/2025, WE ENCOUNTERED A NEW INCIDENT WITH PRODUCT 309646, BATCH 5029101, WITH AN EXPIRATION DATE OF 12/31/2029. TWO PACKAGES OF 5 ML SYRINGES WERE OPENED, AND THEY WERE FOUND TO BE DEFECTIVE: SYRINGE #1: THE NURSE NOTED THAT THE SYRINGE WAS WET. WHEN PRESSING LIGHTLY ON THE PLUNGER, THE MEDICATION SPLASHED AND SPLASHED INTO HER EYE. SYRINGE #2: THE NURSE NOTICED A PERSISTENT LEAK. UPON CLOSER INSPECTION, SHE OBSERVED A CRACK IN THE PLUNGER, AS WELL AS A DEPOSIT OF FLOATING BROWN SEDIMENT INSIDE THE SYRINGE. ATTACHED, YOU WILL FIND PHOTOS ILLUSTRATING TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318948 ↗
• MalfunctionOct 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309646 BATCH#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT THE 5 ML SYRINGES THAT WERE BEING USED WERE DEFECTIVE. THEY WERE LEAKING THROUGH THE PLUNGER, WHICH WOULD HAVE RESULTED IN FAILING THE STERILITY TEST IF THEY WERE SENT OUT OF THE IV ROOM FOR TESTING AND USE. ADDITIONALLY, IN TWO SYRINGES WE NOTICED METALLIC CONTAMINANTS INSIDE THE SYRINGES. THERE WAS ONE CONTAMINANT IN EACH SYRINGE, SMALL AND ROSE-GOLD IN COLOR. THE CONTAMINANTS LOOK SIMILAR TO METAL SHAVINGS OR GLITTER. I ALSO NOTICED IN A FEW OF THE DEFECTIVE SYRINGES THAT THE PLUNGER APPEARED TO BE BREAKING OFF INTO SMALL PIECES INSIDE THE SYRINGE. 40 SYRINGES WERE THROWN AWAY DURING COMPOUNDING DUE TO LEAKING AND THE 2 CONTAMINATED SYRINGES. VERBATIM: THE CUSTOMER NOTICED THAT THE 5 ML SYRINGES THAT WERE BEING USED WERE DEFECTIVE. THEY WERE LEAKING THROUGH THE PLUNGER, WHICH WOULD HAVE RESULTED IN FAILING THE STERILITY TEST IF THEY WERE SENT OUT OF THE IV ROOM FOR TESTING AND USE. ADDITIONALLY, IN TWO SYRINGES WE NOTICED METALLIC CONTAMINANTS INSIDE THE SYRINGES. THERE WAS ONE CONTAMI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278439 ↗
• MalfunctionOct 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278263 ↗
• MalfunctionOct 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD VISIBLE DROPLETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:309646 BATCH#:3212366. RCC RECEIVED A COMPLAINT VIA EMAIL. WHILE OPENING NEW BOX OF BD 5CC SYRINGES LOT NUMBER 3212366, EXP DATE: 2028/07/31, I NOTICED THAT THE OUTER PART (BARREL) APPEARED OLD AND SCRATCHED. ADDITIONALLY, THERE WAS SOME RESIDUE AND MOISTURE INSIDE THE SYRINGES (AT THE PLUNGER SEAL/BLACK RUBBER), WHICH WAS VERY UNUSUAL AND I DO NOT RECALL SEEING MOISTURE BEFORE. ADVISED MY IMMEDIATE SUPERVISOR ON THE PROPER PROCEDURE FOR REPORTING THIS ISSUE AND REQUESTED A QUALITY VERIFICATION. SET A SIDE THE WHOLE BOX IN ORDER TO PREVENT USING THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222396 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110771. One submission often covers many models, so check the product and lot details in each record.

• Z-2614-2026 · Apr 28, 2026 · Open, Classified
  SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
• Z-2751-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2752-2017 · Sep 16, 2016 · Terminated
  BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injec
• Z-2753-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-2747-2017 · Sep 16, 2016 · Terminated
  BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
• Z-2749-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 The BD Single Use, Hypodermic Syringe is intended for use by health care professi
• Z-2750-2017 · Sep 16, 2016 · Terminated
  BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care prof
• Z-1936-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1937-2016 · Mar 25, 2016 · Terminated
  Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
• Z-1055-2015 · Dec 19, 2014 · Terminated
  BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4