N/A 309659Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 30382903096597), received between Nov 28, 2017 and Apr 7, 2026 — classified as 78 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (22 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 1ML LS 200 S/C CONTAINED FOREIGN MATTER. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE HAD 2 DIFFERENT EPISODES TODAY THAT WE HAVE PULLED UP BOTOX AND SEEN A FLOATING BLACK PIECE IN THE SYRINGE THAT WE BELIEVE IS FROM THE PLUNGER. WE DO NOT THINK IT IS THE STOPPER IN THE BOTOX AS THAT IS GRAY. WE HAVE ENTERED SERS AND REMOVED FROM OUR STOCK. BD 1 CC SYRINGE LOT #- 5302330. EXP- 9/30/30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802264 ↗
• MalfunctionOct 31, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444302 ↗
• MalfunctionOct 31, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444290 ↗
• MalfunctionOct 31, 2025Nonstandard Device; Defective Component; Nonstandard Device; Defective Component

  IT WAS REPORTED THAT THE BD SYRINGE 1ML LS 200 S/C PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309659; BATCH # 5204380, 5084373, 5059644. VERBATIM: WHEN DRAWING MEDS, THE PLUNGER ROD PULLS STRAIGHT OUT OF THE SYRINGE BARREL. THERE IS NO CATCH TO IT. LOSS OF MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444241 ↗
• MalfunctionJun 23, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 1ML LS 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: MATERIAL # 309659 BATCH # 5078139 VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED PRODUCTCOMPLAINT REF (B)(4). LOT: 5078139 ISSUE: ON THE PLUNGER LOOKS LIKE THERE IS A SUBSTANCE SMEARED ON THE PLUNGER AREA. NO PT HARM DOE: 29MAY2025 QTY AFFECT 1 BOX SAMPLE YES KT REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311926 ↗
• MalfunctionJun 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 1ML LS 200 S/C HAD FOREIGN MATTER. MATERIAL: 309659, BATCH#: 2355450, VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE FOUND P/N 309659, LOT # 2355450/202609 HAS INK MARK AND DIRT IN THE SYRINGES. I00% INSPECTION CONDUCTED, AND 91 PCS WERE REJECTED/DISPOSED. ADDITIONAL INFORMATION PROVIDED: THE LOT # IS 2355450. DATE OF EVENT IS MARCH 25. NO PATIENT HARM OR INJURY. DEFECT WAS FOUND DURING THE ASSEMBLY PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148811 ↗
• MalfunctionFeb 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL # 309659 BATCH # UNKNOWN, 4040291. IT WAS REPORTED BY CUSTOMER THAT WHEN THEY PUT IN PRIMER SOLUTION (CLEAR IN COLOR) AND IT IS TURNING YELLOW. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE PURCHASED # 309659 AND WITH SEVERAL BATCHES/ LOTS, OUR CUSTOMER IS SAYING WHEN THEY PUT IN PRIMER SOLUTION (CLEAR IN COLOR) AND IT IS TURNING YELLOW (WHICH THEY SAY HAS NEVER HAPPENED BEFORE). THE BATCHES/LOTS THAT HAVE BEEN USED ARE: 3031943, 4040291 AND MOST RECENT 3032625.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306250 ↗
• MalfunctionDec 17, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  POST INVESTIGATION RESULTS INDICATE AN ADDITIONAL FAILURE OF "BARREL / FLANGE DAMAGED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20956353 ↗
• MalfunctionDec 17, 2024Connection Problem; Connection Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20955401 ↗
• MalfunctionDec 17, 2024Connection Problem; Connection Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20955391 ↗
• MalfunctionOct 18, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20485450 ↗
• MalfunctionOct 12, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL#: 309659. BATCH#:4040291, 3031943. IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CALLER CONFIRMS HE IS A DISTRIBUTOR WHO ORDERS SYRINGE 309659 (LOT 4040291 AND LOT 3031943) FOR A CUSTOMER. CALLER STATES THE CUSTOMER SENT AN EMAIL STATING THAT THEY ARE HAVING ISSUES WITH THE SYRINGE. CALLER STATES THE PRIMER FLUID IS TURNING YELLOW. ADDITIONAL INFORMATION PROVIDED: PLEASE PROVIDE DATE OF EVENT. ¿ MONDAY 16 SEP 2024. COULD YOU PLEASE PROVIDE NUMBER OF OCCURRENCES THAT ARE OBSERVED RECENTLY? - THE FIRST TWO SYRINGE USED PRESENT THE CONDITION, THEN WAS REPEAT WITH ONE SYRINGE OF EACH BATCH AND PRESENT THE SAME CONDITION. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? ¿ THE SYRINGE WAS NOT USED IN THE MANUFACTURING PROCESS, SINCE THE CONDITION WAS IDENTIFIED BEFORE USED. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? WAS THIS ISSUE TRACED BEFORE USE OR DURING DRAW OF LIQUID INTO SYRINGE? ¿ WAS IDENTIFIED WHEN THE DRAW THE L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20435185 ↗
• MalfunctionAug 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL #: 309659. BATCH#: 4080570. IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. "I WAS PREPARING MEDICATIONS FOR THE FIRST CATARACT PATIENT OF THE DAY, I PULLED OUT A 1ML SLIP TIP SYRINGE AND NOTICED THE PACKAGE WAS DIRTY. UPON FURTHER INSPECTION THE INTERIOR OF THE PACKAGE WAS ALSO DIRTY. PACKAGE WAS NEVER OPENED." ADDITIONAL INFORMATION PROVIDED: ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? 9000 W SURA LN, GREENFIELD WI 53228 (LOCAL REPRESENTATIVE INFORMED ME HE WAS PICKING UP THE SAMPLE). DID YOU NOTICE ANY UNUSUAL SOUNDS OR SHIFTING INSIDE THE BOX WHEN HANDLING IT? NO CAN YOU DESCRIBE ANY DAMAGE FOUND TO ITEMS INSIDE THE BOX? NO DAMAGE WITHIN THE BOX, SINGLE SYRINGE HAD DIRT WITHIN PACKAGING. CAN YOU DESCRIBE EXTERNAL CONDITION OF THE BOX UPON RECEIPT, ANY SIGNS OF MISHANDLING/OPENED SEALS? BOX HAD NO DAMAGE. ANY PICTURE OF THIS COMPLAINT? YES, PLEASE SEE BELOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078916 ↗
• MalfunctionMay 8, 2024Leak/Splash; Leak/Splash

  MATERIAL # 309659, BATCH # 3212670. IT WAS REPORTED BY CUSTOMER THAT WHEN NEEDING TO USE ON SUB OUT PORT, SYRINGE DOES NOT SECURELY ATTACH TO MICRO CLAVE, RESULTING IN MEDICATION LEAKING AND SYRINGE DETACHMENT, RESULTING IN A POTENTIAL FOR AN ADVERSE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN NEEDING TO USE ON SUB OUT PORT, SYRINGE DOES NOT SECURELY ATTACH TO MICRO-CLAVE, RESULTING IN MEDICATION LEAKING AND SYRINGE DETACHMENT, RESULTING IN A POTENTIAL FOR AN ADVERSE. CAT# OF PRODUCT BEING COMPLAINED: 309659. DESCRIPTION OF PRODUCT: SYRINGE TUBERCULIN L/SL ST 1ML DISP CLR SCALE 200EA/BX 8BX/CA. LOT NUMBER: 3212670.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273602 ↗
• MalfunctionJan 17, 2024Disconnection; Disconnection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530360 ↗
• MalfunctionJan 17, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD LUER-LOK HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN USING THE 1ML TUBERCULIN SLIP TIP SYRINGE WITH BD ECLIPSE NEEDLE SEPARATION OCCURS AT THE JUNCTION POINT CAUSING THE UNSAFE SITUATION AS THE NEEDLE IS EXPOSED BEFORE ADMINISTERING MEDICATION AND THERE IS A CHANCE OF STAFF ACCIDENTALLY POKING THEMSELVES. ANOTHER INCIDENT OCCURED WHERE THE SYRINGE DISLODGED FROM THE NEEDLE WHILE WITHDRAWING THE INJECTION, LEAVING THE NEEDLE IN THE PATIENTS BODY. THE NEEDLE HAD TO BE THEN REMOVED SEPARATELY, CREATING UNSAFE SITUATION." IMPACT OF INCIDENT: OUTCOME WAS PROLONGED AGITATION FOR THE PATIENT AS THE MEDICATION ADMINISTRATION WAS DELAYED. AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2023. SITE NAME/LOCATION: (B)(6) MEDICAL CENTRE. LEVEL OF HARM: NO APPARENT HARM ¿ CLOSE CALL. AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: WHEN USING THE 1ML TUBERCULIN SLIP TIP SYRINGE WITH BD ECLIPSE NEEDLE SEPARATION OCCURS AT THE JUNCTION POINT CAUSING THE UNSAFE SITUATION AS THE NEEDLE IS EXPOSED BEFORE ADMINISTERING MEDICATION AND THERE IS A CHANCE OF STAFF A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528440 ↗
• MalfunctionDec 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ORDERED 2 BOXES OF THE 1ML SYRINGES AND THE PACKAGES OF SYRINGES HAD DIRT OR DEBRIS IN THE SEALED PACKAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371257 ↗
• MalfunctionDec 19, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354515 ↗
• MalfunctionOct 2, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PLUNGER FOR THE BD® LUER SLIP TIP SYRINGE STERILE WAS DIFFICULT TO MOVE. THE FOLLOWING WAS RECEIVED FROMT THE INITIAL REPORTER: STOPPER IS VERY TIGHT. STOPPER IS UNABLE TO MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857926 ↗
• MalfunctionAug 17, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT WHILE USING THEBD® LUER SLIP TIP SYRINGE STERILE THERE WERE VOLUME ACCURACY ISSUES. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER CALLED IN TO REPORT THAT WHEN ADMINISTERING MEDICATION TO PATIENT THEY ARE NOTICING THAT THERE IS STILL MEDICATION LEFT IN THE BARREL AFTERWARDS. ISSUE WAS NOTICED LAST WEEK SOMETIME.

  Patient problems: Insufficient Information

  MAUDE report 17569221 ↗
• MalfunctionJul 7, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT THE BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USE, PRODUCT WAS FOUND TO HAVE DISCOLORED MATERIAL ON BARREL OF SYRINGE, AT FIRST MISTAKEN FOR CONTAMINANT/PARTICULAR INSIDE OF BARREL/SOLUTION, BUT UPON DISASSEMBLY THE MATERIAL OF THE BARREL ITSELF PRESENTS WITH DARK BROWN SPOTS/FLECKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17281207 ↗
• MalfunctionMay 12, 2023Contamination; Contamination

  IT WAS REPORTED THAT 500 BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGES WERE FOUND WITH FOREIGN MATTER INSIDE THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PER COMPLAINT, PHARMACY FOUND BLACK DOT/POWDER LIKE MATERIAL ON THE PLUNGER OF THE MULTIPLE 1ML BD SYRINGE FROM THE LOT 2355450... CAN YOU PLEASE CONFIRM THESE SYRINGES DID NOT COME IN CONTACT WITH ANY PATIENTS AND THERE WAS NO HARM? ANS: YES, I CONFIRM THAT THESE SYRINGES DID NOT COME IN CONTACT WITH ANY PATIENT AND THERE WAS NO HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920262 ↗
• MalfunctionApr 20, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NOTICED VISIBLE CONTAMINATION ON AN UNOPENED STERILE BD 1 ML TUBERCULIN SLIP-TIP SYRINGE (REF (B)(4)). THE LOT NUMBER IS 2203500. OUR LAB USES THESE SYRINGES IN PROKARYOTIC MICROBIAL RESEARCH WITH NO DIRECT HUMAN HEALTH APPLICATIONS. I CAN'T ASCERTAIN WHETHER THE RESIDUE IS ONLY ON THE OUTSIDE OF THE SYRINGE OR ACTUALLY INSIDE THE TIP WITHOUT OPENING THE STERILE WRAPPER. ALL I CAN SAY WITH CERTAINTY IS THAT THE DISCOLORATION IS ON THE SYRINGE ITSELF, NOT JUST THE INSIDE OF THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781764 ↗
• MalfunctionApr 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE STOPPER BROKE OFF INSIDE THE BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE. THIS OCCURRED WITH 5 SYRINGES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DESCRIPTION: THE BLACK TIP OF THE 1ML TUBERCULIN SLIP TYPE SYRINGE BREAKS OFF IN THE BARREL OF THE SYRINGE. COMPLAINT NOTICED: DURING / AFTER USE. PATIENT INJURY: NO".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16729066 ↗
• MalfunctionMar 20, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE, THE PLUNGER IS SEPARATING FROM THE STOPPER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER IS DISCONNECTING FROM THE STOPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573826 ↗

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-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-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-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-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-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-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-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