N/A 302995Recalls & reported problems

Summary

The FDA's MAUDE database contains 537 adverse event reports that list this exact device (DI 00382903029952), received between Oct 17, 2017 and Sep 28, 2026 — classified as 2 injuries, 535 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (137 reports).

1 FDA recall record name this device's identifier, 1 still open.

9 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.

Recalls naming this device

1. Apr 28, 2026Open, Classified

   A single lot of expired syringes were distributed due to a distribution system control failure.

   Z-2614-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 537 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921298 ↗
• MalfunctionSep 21, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849039 ↗
• MalfunctionSep 21, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843268 ↗
• MalfunctionSep 21, 2026Activation, Positioning or Separation Problem

  It was reported that BD SYRINGE 10ML LL S/C 200 stopper separation from plunger.Verbatim: complaint via email. Email(s) attached.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.Alberta Optional Report to CMDSNet (health Canada): yes.Incident Details: While drawing blood cultures off arterial line with 10 ml syringe, black seal noted to have separated from plunger resulting in blood spillageProcedure: Blood draw.Device InformationDevice Name/Description: SYRINGE LUER LOCK TIP 10ML.Manufacturer code/model: 302995.Serial or Lot number: (b)(6).Expiry date: 2030-12-31.Supplier/Catalogue number: 308-302995.Is the device retained? Yes.Number of devices: 1.I apologize for the miscommunication, but the device was not retained due to gross blood contamination.It was initially retained by the RN, and discarded after the RLS was filed.

  Patient problems: Exposure to Body Fluids

  MAUDE report 50842489 ↗
• MalfunctionSep 15, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775092 ↗
• MalfunctionSep 11, 2026Contamination /Decontamination Problem

  It was reported that BD SYRINGE 10ML LL S/C contained foreign matter.Verbatim:Complaint via email. Email(s) attached.Caller asked to clarify the location of the moisture. Is the moisturenoted in the barrel or package. Caller informed that BD syringecontains a medical grade silicone lubricant. If the moisture is insidethe syringe, it could be the silicone lubricant. If it's in the package,it could be a humidity/temperature issue. Per caller the moisture inthe barrel of the syringe. Advised following instructions given byproduct complaints. Caller requested document stating thematerials of the syringe. Emailed the syringe TDS per request.Caller advised to have customer reach out to us directly at xxxx with questions.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736914 ↗
• MalfunctionSep 8, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676790 ↗
• MalfunctionSep 8, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676784 ↗
• MalfunctionAug 17, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287701 ↗
• MalfunctionAug 17, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287699 ↗
• MalfunctionAug 17, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287697 ↗
• MalfunctionAug 17, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287696 ↗
• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225443 ↗
• MalfunctionAug 4, 2026Leak/Splash

  It was reported that BD SYRINGE 10ML LL S/C 200 had leakage past stopper.complaint via email.I am reaching to inform you that we have had another syringe (302995) with leaking issues. Unfortunately, the lot number on the syringe was not retained. The actual syringe was retained and available for further investigation if needed. I also have a follow up question regarding the close out letter I received back in May (Ref number: (b)(4). With the investigation results, it was identified that the probable root cause of the barrel cracking and leakage is during the assembly process. Is this referring to user error like over tightening or is this during the manufacture assembly process?Hello, Please see the question from (b)(6) at (b)(6) below.According to the PIR response letter, the cause of the cracks in their 302995 is the "assembly process".Is this referring to BD's assembly process or the end users?Thank you for clarifying.Decker, (b)(6). Product Complaints:Value Analysis <[email protected] you for this information. I know this question will likely come up when I share the update with our team. Are there any improvement initiatives or investigations currently underway to h

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50127304 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT BD SYRINGE 10ML LL S/C 200 LUER WAS CRACKED / DAMAGED / DEFORMED. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN ATTEMPTING TO DISCONNECT SYRINGE ON VENOUS MEDICATION PORT THE MALE PART OF THE SYRINGE BROKE OFF AND WAS STUCK IN THE MEDICATION PORT. THERE WASN¿T ANY INDICATION OF IT BEING SAVED BUT I AM REACHING OUT TO THE NURSE TO SEE IF THERE WERE ANY PHOTOS TAKEN OF THE INCIDENT SO I WILL GET BACK TO YOU ON THIS. LUCKILY, THEY WERE DONE ADMINISTERING THE MEDICATION AND DIDN¿T NEED THE PORT ANYMORE. NO HARM DONE TO THE PATIENT AS THE PORT HAS A CHECK-VALVE AND CAN ONLY GO ONE-WAY. ONLY POTENTIAL CONCERN IS THAT IF THE PATIENT NEEDED MEDICATION, THEY WOULD HAVE TO USE ANOTHER PORT FURTHER AWAY FROM THE PATIENT BUT WOULDN¿T CAUSE AN IMMEDIATE RISK. JUST AN UPDATE, THEY DIDN¿T SAVE THE SAMPLE AND UNFORTUNATELY NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417180 ↗
• MalfunctionMay 21, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 10ML LL S/C 200 CONTAINED FOREIGN MATTER. VERBATIM: COMPLAINT VIA EMAIL. OPENED UP A BD 10 ML LUER-LOK SYRINGE IN THE STERILE COMPOUNDING SPACE AND INSIDE THE SEALED PACKAGE APPEARED TO BE MOLD OR LINT INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243881 ↗
• MalfunctionMay 14, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 10ML LL S/C 200 CONTAINED FOREIGN MATTER. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PLEASE SEE ATTACHED SYRINGE 10ML HAS A BLACK MARKING. LOT 5232581. HAS BEEN OPENED BUT NOT USED. CAN SEND BACK FOR REVIEW / INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174846 ↗
• MalfunctionMay 1, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 10ML LL S/C CONTAINED FOREIGN MATTER. "OUR TECH WAS COMPOUNDING IN THE IV ROOM AND OPENED A SYRINGE TO DRAW UP DRUG WHEN SHE NOTICED SOMETHING ODD WITH THE SYRINGE. THE PACKAGING HAD SOME BLACK STUFF ON THE INSIDE AND SHE ALSO NOTICED THE HUB OF THE SYRINGE HAD IT IN IT AS WELL. THE PRESUMPTION IS THAT IT IS MOLD. PER DESCRIPTIONS WE HAVE RECEIVED, DOESN'T APPEAR TO HAVE BEEN INK BLOTTING AS IT IS FUZZY LIKE MOLD. WHEN WE ASKED THE PHARMACISTS ABOUT IT, THEY STATED IT WAS VERY CLEARLY FUZZY. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057676 ↗
• MalfunctionApr 14, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 10ML LL S/C CONTAINED FOREIGN MATTER. COMPLAINT VIA EMAIL. I AM CONTACTING YOU FROM THE X TO REPORT A PRODUCT DEFECT. WE RECEIVED A REPORT OF A 10 ML SYRINGE PACKAGE CONTAINING DEBRIS. REF: 302995, LOT: 6047494, EXP. 01/31/2031. PLEASE LET US KNOW IF YOU NEED ANY ADDITIONAL INFORMATION FROM OUR TEAM. THIS DEFECT WAS IDENTIFIED ON (B)(6) 2026. THE PHYSICAL SAMPLE IS AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24880357 ↗
• MalfunctionApr 3, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 10ML LL S/C CONTAINED FOREIGN MATTER. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON 3/11/2026, DURING COMPOUNDING OF LOT 20260311-25595F, TWO SYRINGES WERE DISCOVERED TO HAVE A DEFORMED PLUNGER. DURING VISUAL INSPECTION, ONE SYRINGE WAS DISCOVERED TO CONTAIN A FOREIGN PARTICULATE, WHICH APPEARS TO BE A HAIR. THE SYRINGES WERE FILLED, AND OUR PROCESS REQUIRES US TO SEND OUT ALL FILLED UNITS FOR TESTING, THEREFORE THEY NOT AVAILABLE FOR RETURN. DETAILS FOR YOUR INVESTIGATION: PRODUCT: 10 ML SYRINGE. LOT NUMBER: 4354523. PART NUMBER: 302995. NUMBER OF DEFECTIVE UNITS: 3. DEFECT TYPE: SYRINGE WITH DEFORMED PLUNGER. SYRINGE WITH FOREIGN PARTICULATE. PRODUCT COMPLAINT: (B)(4). QUANTITY : (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778457 ↗
• MalfunctionMar 23, 2026Material Separation

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 STOPPER WAS JAMMED / INSECURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 302995 LOT # 5239494 IT WAS REPORTED BY CUSTOMER THAT O RING FAILURE. VERBATIM: COMPLAINT VIA EMAIL WE HAVE RECEIVED A COMPLAINT FROM ONE OF OUR USERS REGARDING A FAILURE DURING USE OF A 10 CC SYRINGE DURING A PLATELET SEPARATOR PROCEDURE. PRODUCT NAME AND/OR CATALOG NUMBER: 302995/ SYRINGE 10ML LL S/C 200 LOT NUMBER OR SERIAL NUMBER: LOT #:5239494 ANY INJURIES AND/OR HARM? NO WHAT IS THE ISSUE YOU EXPERIENCED? O RING FAILURE IS THE ACTUAL SAMPLE OR SAMPLE REPRESENTATIVE AVAILABLE? (IF POSSIBLE, PLEASE SEND AFFECTED SAMPLE) NOT AVAILABLE TO SEND. REFER TO ATTACHED IMAGES. CONTACT NAME AND PHONE NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24665330 ↗
• MalfunctionMar 23, 2026Leak/Splash

  IT WAS REPORTED THAT BD SYRINGE 10ML LL S/C 200 HAD LEAKAGE PAST THE STOPPER. VERBATIM: PHARMACY HAS REPORTED FOUR INCIDENTS WHERE BLOOD HAS LEAKED OUT THE BACK OF THE SYRINGE, PAST THE PLUNGER. THESE SYRINGES ARE USED BY PHARMACY TO PREPARE HEPARIN 9,000 U/9 ML, WHICH IS THEN SENT OUT FOR TEAMS TO FLUSH HD LINES. ADDITIONAL INFORMATION RECEIVED ON 26FEB2026. THE MANUFACTURE NUMBER FOR THE SYRINGE IS 302995. WE UNFORTUNATELY DO NOT HAVE A LOT NUMBER TO PROVIDE OR EVEN THE DEFECTIVE PRODUCT TO RETURN. TEAMS THREW IT AWAY BEFORE REACHING OUT TO US. IF WE CONTINUE TO HAVE ISSUES, I HAVE ASKED TEAMS TO RETAIN THE SYRINGES FOR FURTHER INVESTIGATION. I DID FOLLOW UP WITH THE UNIT THAT ORIGINALLY SUBMITTED THE COMPLAINT AND THEY ADVISED THEY DO HAVE FOUR SYRINGES THAT COULD BE SHIPPED BACK FOR INVESTIGATION IF WE ARE PROVIDED WITH A SHIPPING LABEL.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24661086 ↗
• MalfunctionMar 20, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 10ML LL S/C 200 CONTAINED FOREIGN MATTER. VERBATIM: UNOPENED SYRINGE HAD MOLD IN PACKAGING. ISSUE CAUGHT PRIOR TO PHARMACY COMPOUNDING. NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650232 ↗
• MalfunctionMar 19, 2026Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24640785 ↗
• MalfunctionMar 19, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 10ML LL S/C 200 CONTAINED FOREIGN MATTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I HAVE BEEN USING 10ML LUER LOK TIP SYRINGE (REF 302995); HOWEVER, I NOTICED THAT LOT 3125095 SEEMS TO HAVE MORE SILICONE OIL THAN ANOTHER LOT 4290876. I WAS WONDERING IF YOU HAVE A SYRINGE PRODUCT COMPARABLE TO 302995 BUT WITHOUT ANY SILICONE OIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640157 ↗

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-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-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-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-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-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-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