BD Luer-Lok 309642Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00382903096428), received between Jan 18, 2017 and May 19, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (28 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Crack

  IT WAS REPORTED THAT BD SYRINGE 10ML LL W/NDL 21X1 RB BARREL WAS CRACKED. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED SYRINGE PLACED IN HEPRIN PUMP ON 2008T MACHINE. MACHINE WAS STARTED WITH NO ISSUES. WITHIN TWO MINUTES OF STARTING PT, EXPERIENCED MAJOR BLOOD LOSS IN ONE PATEINT AND MINOR IN ANOTHER DUE TO CRACKED NEEDLES/ISSUES WITH THE INTERNAL RUBBER COMPONANTS OF THE SYRINGE. UPON FURTHER INSPECTION, NUMEROUS WERE CRACKED/BROKEN/DAMAGED AND UNUSEABLE. ALL NEEDLES WITH THIS LOT NUMBER WERE PULLED FROM THE FLOOR AND PLACED SEPERATE FROM USEABLE MATERIALS CUSTOMER RESPONSE ON (B)(6) 2026. THE SYRINGES WER CRACKED AND HAVE BEEN SENT BACK ALREADY SO WE AREN'T ABLE TO PROVIDE ANY PHOTOS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25218577 ↗
• MalfunctionMay 19, 2026Crack

  CUSTOMER RESPONSE ON 18-MAY-2026. DID EITHER PATIENT REQUIRE MEDICAL INTERVENTION DUE TO THE "BLOOD LOSS" PATIENT WENT TO OUTPATIENT LAB TO HAVE HGB CHECKED DUE TO BLOOD LOSS. DID EITHER PATIENT REQUIRE A BLOOD TRANSFUSION? NO. WAS SYRINGE REPLACED AND TREATMENT COMPLETED? YES. DID PUMP ALARM? OR WAS HEPARIN LEAKING OUT OF PUMP WHEN DEFECT WAS NOTICED? NO MACHINE ALARMS. BLOOD WAS FOUND LEAKED OUT OF THE SYRINGE DOWN THE MACHINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25218565 ↗
• MalfunctionDec 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 309642 BATCH#: 5232394. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER XXX REPORTED RECEIVING ITEM# BF309642 WITH BLACK LIQUID/SUBSTANCE ON THE TOP PART. PLEASE SEE ATTACHED. WAITING FOR CUSTOMER ADDITIONAL INFORMATION. - PURCHASE ORDER NUMBER - QUANTITY PURCHASED - QUANTITY AFFECTED WOULD LIKE TO REPORT THAT ITEM BF309642 HAS A BLACK SUBSTANCE IN THE NEEDLE AREA. (CUSTOMER EMAIL COPY ATTACHED WITH PICTURES)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816479 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21X1 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309642 BATCH # 5064172 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED CONTACT NAME: **** CONTACT NUMBER: **** CONTACT EMAIL (IF AVAILABLE): ITEM(S): 309642 LOT(S): 5064172 DATE INCIDENT OCCURRED:ONGOING FOR A COUPLE OF WEEKS WAS THE PATIENT IMPACTED? IF YES, DESCRIBE: WHEN REMOVING THE CAP, THE NEEDLE FALLS OFF. HAS TRIED TO TWIST/TIGHTEN BEFORE REMOVING CAP, BUT NEEDLE STILL FALLS OFF. IT¿S NOT EVERY NEEDLE, BUT THIS WEEK HAS BEEN 7 IS A SAMPLE AVAILABLE?: YES CUSTOMER REQUEST?: CUSTOMER NEEDS REPLACEMENTS TO BE ABLE TO TAKE MEDICATIONS ADDITIONAL INFORMATION RECEIVED ON 31JUL2025: CUSTOMER CALLED ON 31JUL2025 WITH HER EMAIL AND PHYSICAL ADDRESS. SHE STATES THAT SHE DID GET POKED AS A RESULT OF THE DEFECT. NO MEDICAL ATTENTION WAS NEEDED. SHE IS REQUESTING A RETURN LABEL AND KIT TO BE SENT TO HER ADDRESS. PLEASE MAKE SURE TO INCLUDE HER EMAIL ADDRESS IN THE LATEST FOLLOW UP WITH RETURN LABEL (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22723379 ↗
• MalfunctionJul 30, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22670622 ↗
• MalfunctionJun 23, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:309642 & BATCH#:5093194. VERBATIM: WE RECEIVED LOT NUMBER 5093194 OF SYRINGE BD309642, AND WE NOTICED THE APPARENT PRESENCE OF POWDER INSIDE THE SYRINGE (SEE ATTACHED PHOTO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312171 ↗
• MalfunctionJun 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 309642 BATCH # 5015056 VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. REF 309642 LOT UNKNOWN ISSUE: BLACK RING AROUND SYRINGES WHEN PACKAGE IS OPENED, APPEARS TO BE IN THE FLUID PATHWAY. DOE: 03JUNE2025. NO PT HARM SAMPLES YES QTY: ALL THREE CASES. NOTE: SUPPLIER IS EMAILING PICTURES AND ORIGINAL EMAIL NOTIFICATION FROM CUSTOMER. SUPPLIER IS SEEKING CREDIT, PLEASE INCLUDE SUPPLIER IN ALL COMMUNICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302709 ↗
• MalfunctionMay 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN HAD LEAKAGE PAST THE STOPPER. MATERIAL # 30964220, LOT # 4302761. IT WAS REPORTED BY CUSTOMER THAT IT WAS LEAKING PAST STOPPER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED, LEAKING AT THE STOPPER, PRODUCT NUMBER - 30964220. LOT#: 4302761.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955586 ↗
• MalfunctionMar 14, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610017 ↗
• MalfunctionFeb 21, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438612 ↗
• MalfunctionFeb 20, 2025Leak/Splash; Leak/Splash

  MATERIAL #30964220. LOT #UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PLEASE NOTE THE ATTACHED COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY (B)(6). (B)(6) WAS NOTIFIED VIA EMAIL THAT THE 10ML SYRINGES WERE LEAKING AROUND THE RUBBER STOPPER WHEN DRAWING UP MEDICATIONS. PATIENTS USING HEPARIN PUMPS EXPERIENCED BLOOD-FILLED SYRINGES LEAKING FROM THE RUBBER STOPPER. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2) MODEL #: 15-6422-0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421771 ↗
• MalfunctionJan 29, 2025Leak/Splash; Leak/Splash

  MATERIAL #:30964220 BATCH#:3264115. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY A CLINICAL MANAGER VIA EMAIL THAT FLUIDS ARE LEAKING THROUGH THE BARREL OF THE 10ML SYRINGES WHEN PULLING AND PUSHING MEDICATIONS, LEADING TO SPILLS OF BLOOD AND MEDICATION. COMPLAINT#: (B)(4) PRODUCT:BD 10ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270342 ↗
• MalfunctionJan 24, 2025Crack; Crack

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230543 ↗
• MalfunctionJan 14, 2025Leak/Splash; Leak/Splash

  MATERIAL # 30964220, BATCH # 3264115. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT NAME: BD 10ML SYRINGE. MATERIAL/CATALOG NUMBER: REF: (B)(4) SERIAL#: (B)(6). LOT NUMBER(S): 00382903096428. DATE OF INCIDENT (B)(6) 2024. DATE BD NOTIFIED, IF APPLICABLE 12/20/24. NAME OF BD ASSOCIATE INFORMED, IF APPLICABLE (FIRST AND LAST NAME): DESCRIPTION OF EVENT: MULTIPLE 10ML SYRINGES LEAKING AROUND RUBBER STOPPER WHEN DRAWING UP MEDS. PTS ON HEPARIN PUMP ALSO LEAKING BLOOD FILLED SYRINGE FROM THE RUBBER STOPPER. SAMPLE AVAILABILITY: YES- HAVE UNCONTAMINATED SYRINGE FROM SAME LOT THAT LEAKED WHEN DRAWING UP FLUID. WAS THERE ANY ALLEGED INJURY OR HARM TO USER OR PATIENT? HEPARIN PUMP LEAKING BLOOD THROUGH THE SYRINGE STOPPER ONTO THE MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149502 ↗
• MalfunctionJan 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. IT WAS REPORTED TO (B)(6) BY A CHARGE NURSE VIA EMAIL THAT 10CC SYRINGE PLUNGER NOT WORKING. BLOOD + MEDICATIONS LEAK PAST SYRINGE PLUNGER. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). LOT #: 3264115.

  Patient problems: Insufficient Information

  MAUDE report 21143924 ↗
• MalfunctionJan 13, 2025Leak/Splash; Leak/Splash

  MATERIAL # 30964220. LOT # 3264115. IT WAS REPORTED THAT THE SYRINGE 10ML LL W/NDL 21GX1IN HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) RECEIVED A COMPLAINT VIA EMAIL. IT WAS REPORTED TO (B)(6) BY A REGISTERED NURSE VIA FAX BLOOD BACKING UP INTO SYRINGE, LEAKING INFUSION PORT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Insufficient Information

  MAUDE report 21138178 ↗
• MalfunctionJan 5, 2025Defective Device; Defective Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076470 ↗
• MalfunctionJan 5, 2025Defective Device; Defective Device

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076436 ↗
• MalfunctionJan 5, 2025Defective Device; Defective Device

  MATERIAL: 30964220. LOT: 3264115. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN BARREL FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY A CLINICAL MANAGER VIA EMAIL THAT ON (B)(6)2024. THE SYRINGE IS LEAKING FROM THE STOPPER SIDE, AND THERE ARE NOTICEABLE DENTS AND IRREGULARITIES IN ITS SHAPE. COMPLAINT#: (B)(4). PRODUCT: BD 10ML LUER-LOK SYRINGE 21GX1IN_3096422. PRODUCT #: 15-6422-0. LOT NUMBER#: 3264115. ADDITIONAL INFORMATION PROVIDED: 1) CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 2/12/2024, 03/12/22024, 04/12/2024. 2) WHAT WAS THE IMPACT TO THE PATIENT? ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE EVENT, MEDICATION OVERSPILL AND BLOOD LEAK BUT DETECTED AND RESOLVED BEFORE TURNING INTO ADVERSE EVENT. 3) 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? SAMPLE AVAILABLE. CLINIC ADDRESS - (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076435 ↗
• MalfunctionDec 27, 2024Defective Device; Defective Device

  MATERIAL #:30964220; BATCH#:3264115. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE 10CC SYRINGE PLUNGER NOT WORKING AND BLOOD / MEDICATIONS LEAK PAST SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT#: (B)(4), PRODUCT: BD 10ML LUER-LOK SYRINGE 21GX1IN_3096422, PRODUCT #: 15-6422-0 AND LOT NUMBER#: 3264115. COMPLAINT: IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY A CHARGE NURSE VIA EMAIL THAT 10CC SYRINGE PLUNGER NOT WORKING. BLOOD + MEDICATIONS LEAK PAST SYRINGE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026668 ↗
• MalfunctionDec 27, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. BLOOD BACKING UP INTO SYRINGE; LEAKING INFUSION PORT. ITEM - 3096422 LOT - 3264115. ADDITIONAL INFORMATION PROVIDED: 1) CAN YOU PLEASE PROVIDE DATE OF EVENT? 2) THE PROVIDED MATERIAL NUMBER 3096422, NOT MATCH WITH BATCH NUMBER 3264115. CAN YOU PLEASE PROVIDE MATERIAL NUMBER IF AVAILABLE? 3) ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? 4) PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. 5) ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 1. DATE OF EVENT 12-3-2024 3. THE 2 BOXES OF SYRINGES HAVE BEEN SEQUESTERED AN ARE AVAILABLE FOR INVESTIGATION 4. NO PICTURE AVAILABLE 5. AMOUNT OF BLOOD LOSS WAS NOT SUFFICIENT FOR AN ADVERSE EVENT. CLINIC ADDRESS IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026666 ↗
• MalfunctionJul 10, 2024Crack; Crack

  MATERIAL #: 309642 BATCH#: 3095864 IT WAS REPORTED THAT THE BD LUER-LOK BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CLINIC MANAGER (CM) REPORTED TO COSTUMER SERVICE 2 SYRINGES THAT HAD VISIBLE CRACKS IN THE BARREL AND WHEN STAFF USED PRODUCT TO FILL WITH HEPARIN, THE HEPARIN LEAKED THROUGH THE CRACK IN THE SYRINGE. REPORTED TO CM BY PCT FACILITY." PRODUCT: BD 10ML LUER-LOK SYRINGE 21GX1IN PRODUCT - 309642 LOT - 3095864

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709843 ↗
• MalfunctionApr 30, 2024Volume Accuracy Problem; Volume Accuracy Problem

  MATERIAL: 309642 BATCH#: 3324733 IT WAS REPORTED THAT THE BD LUER-LOK HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD 10ML LUER-LOK SYRINGE 21GX1IN HAD NO MEASUREMENT MARKINGS." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED FRESENIUS CUSTOMER COMPLAINT (B)(4). CUSTOMER: XXXX PRODUCT: BD 10ML LUER-LOK SYRINGE 21GX1IN VENDOR PART#: 309642 LOT NUMBER: 3324733 COMPLAINT: IT WAS REPORTED TO XXXXXX THAT A BD 10ML LUER-LOK SYRINGE 21GX1IN HAD NO MEASUREMENT MARKINGS. DEAR CUSTOMER COMPLAINTS: THE PURPOSE OF THIS LETTER IS TO NOTIFY YOU, THE MANUFACTURER, THAT XXXXX NA, DISTRIBUTORS OF YOUR BD 10ML LUER-LOK SYRINGE 21GX1IN, RECEIVED THE ABOVE COMPLAINT. FRESENIUS MEDICAL CARE NA REQUESTS THAT YOUR ORGANIZATION ADDRESS ANY FOLLOW-UP INVESTIGATION DIRECTLY WITH THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217740 ↗
• MalfunctionApr 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT COLIN SPICER REPORTED TO FRESENIUS MEDICAL CARE THAT ON 02/20/2024 THE FLOOR STAFF TOLD HIM THAT THERE WAS BLOOD LEAK FROM THE 10ML SYRINGES AND THAT IT HAS HAPPENED 3 TIMES THIS LAST MONTH. HE STATED THAT IT SEEMS TO BE A REPEATED ISSUE WITH THESE SYRINGES FOR SOME REASON. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. FRESENIUS CUSTOMER COMPLAINT (B)(4). CUSTOMER: (B)(6) PRODUCT: BD 10ML LUER-LOK SYRINGE 21GX1IN VENDOR PART#: 309642 LOT NUMBER: 3284426 FACILITY: (B)(6): (B)(6) REPORTED TO FRESENIUS MEDICAL CARE THAT ON 02/20/2024 THE FLOOR STAFF TOLD HIM THAT THERE WAS BLOOD LEAK FROM THE 10ML SYRINGES AND THAT IT HAS HAPPENED 3 TIMES THIS LAST MONTH. HE STATED THAT IT SEEMS TO BE A REPEATED ISSUE WITH THESE SYRINGES FOR SOME REASON.

  Patient problems: Insufficient Information

  MAUDE report 19081590 ↗
• MalfunctionMar 8, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/NDL 21GX1IN HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A CLINIC FILE A COMPLAINT FOR FAULTY BD 10 ML SYRINGE LUER-LOCK TIP WITH BD PRECISION GLIDE NEEDLE. THE CLINIC REPORTED THAT MULTIPLE SYRINGES WERE LEAKING FROM THE STOPPER. THERE WAS ONLY ONE CLINIC WHO REPORTED THIS ISSUE AT THIS TIME." PLEASE SEE PRODUCT AND LOT INFORMATION BELOW PRODUCT: 10 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 21 G X 1 IN. MFR PART #: 30964220 LOT#: 3233242 CAN YOU PLEASE FORWARD/SHARE WITH THE APPROPRIATE PARTIES FROM BD TO ADDRESS THIS ISSUE. ALSO, HAVE YOU HEARD OF ANY OTHER CUSTOMERS COMPLAIN ABOUT THIS PRODUCT/LOT NUMBER. ADDITIONAL INFORMATION PROVIDED ON 02/21/2024: 1. CAN YOU PLEASE PROVIDE A EXACT DATE OF EVENT? A. I BELIEVE MONDAY, (B)(6) 2024. 2. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? A. MULTIPLE SYRINGES LEAKING FROM STOPPER ¿ SAME LOT: 3233242. 3. WHERE SPECIFICALLY WAS THE LEAKAGE? A. STOPPER. 4. WERE THERE ANY NOTICEABLE DEFECTS ON THE LUER / STOPPER / CONNECTION / NEEDLE? A. NOT TO MY KNOWLEDGE. 5. IF PAST THE STOPPER, WAS IT ALL THE WAY PAST THE STOPPER OR O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865110 ↗

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-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-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-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-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