BD Luer-Lok 303310Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00382903033102), received between Mar 27, 2021 and Apr 7, 2026 — classified as 82 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (24 reports).

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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 HAD VISIBLE DROPLETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:303310 BATCH#:5253925. PLEASE SEE THE INFORMATION BELOW FROM REGARDING AN ISSUE THEY ARE REPORTING WITH CAN YOU PLEASE START A QI AND WORK WITH TO GATHER ANY ADDITIONAL INFORMATION YOU MAY NEED? PLEASE INCLUDE THE DEFECTIVE TRACKING TEAM IN ANY CORRESPONDENCE FOR THE TRACKING/DOCUMENTATION. THIS REPORT'S UNIQUE IDENTIFIER IS 1497 SHOULD YOU NEED TO REFERENCE IT. REPORT DATE: (B)(6) 2026 PRODUCT DESCRIPTION: BD 20CC LUER-LOK SYRINGE MANUFACTURER PRODUCT NUMBER: REF303310 LOT NUMBER: 5253925 IS PRODUCT IN A KIT/CUSTOM PACK: YES DATE OF EVENT: 2026-03-31 DESCRIPTION OF DEFECT: MOISTURE INSIDE BARREL OF SYRINGE, DROPLET IN GAP BETWEEN RUBBER ON PLUNGER AND HUB OF BARREL. USED ON PATIENT: NO LOCATION OF PRODUCT: INPATIENT PHARMACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807881 ↗
• MalfunctionFeb 23, 2026Contamination

  IT WAS REPORTED THAT BD SYRINGE 20ML LL S/C 50 CONTAINED FOREIGN MATTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE ARE FINDING BLACK FLOATIES IN YOUR BD 20ML SYRINGE. WE HAVE PULLED ALL 20 ML SYRINGES FROM MY AREA. THE ONES THAT ARE IN THE MYELOGRAM TRAY HAVE THEM AS WELL. I HAVE A SYRINGE AND THE WRAPPER FOR THE INCIDENT ON 2/4 THAT I SENT THE PICTURE OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415540 ↗
• MalfunctionFeb 4, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD SYRINGE 20ML LL S/C 50 CONTAINED FOREIGN MATTER. RCC RECEIVED A COMPLAINT VIA EMAIL. WE ARE FINDING BLACK FLOATIES IN YOUR BD 20ML SYRINGE REF 303310. WE HAVE PULLED ALL 20 ML SYRINGES FROM MY AREA. THE ONES THAT ARE IN THE MYELOGRAM TRAY HAVE THEM AS WELL. DO YOU HAVE A FORM THAT CAN BE FILLED OUT ABOUT THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260701 ↗
• MalfunctionJan 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 303310, BATCH#: 5163348. VERBATIM: GOOD AFTERNOON, WE RECEIVED A REPORT FROM OUR XXXX CLINICIANS CONCERNING AN EVENT THEY HAVE EXPERIENCED WHILE USING A SYRINGE 20ML LL STERILE LATEX FREE (303310). LOT# 5163348. THE EVENT DATE IS 12.20.2025. NO HARM TO THE PATIENT HAS BEEN REPORTED. THE COMPLAINT IS DESCRIBED: PARTICULATE FOUND IN THE GASKET OF 20ML BD LUER-LOK TIP SYRINGE. REF 303310. LOT 5163348, EXP 2030-06-30. SEQUESTERED IN WP11 PHARMACY SATELLITE BY THE STERILE PRODUCTS PHARMACIST DESK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23999141 ↗
• MalfunctionJan 6, 2026Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977766 ↗
• MalfunctionJan 4, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 303310; BATCH#: 5132719. VERBATIM: 2 DIFFERENT SYRINGES HAD PARTICULATE IN THE SYRINGE PRIOR. THE PARTICLES WEREN'T PRESENT IN THE SOLUTION PRIOR TO USE AND WAS DETERMINED TO BE IN THE SYRINGE. IMAGES ARE ATTACHED BUT THE 2 FAULTY ITEMS ARE STILL IN THE CUSTOMER'S OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953930 ↗
• MalfunctionNov 27, 2025Crack; Leak/Splash; Crack; Leak/Splash

  ADDITIONAL INFORMATION: WHERE WAS THE CRACK? ¿ THE BARREL AND BARREL FLANGE. WHICH CLOSED SYSTEM WAS THE SYRINGE ATTACHED TO? - CHEMOLOCK. DID THE SYRINGE LEAK WHERE THE CRACK WAS - YES SOME LIQUID LEAKED OUT THE SYRINGE BARREL WHERE THE SYRINGE WAS CRACKED AND THE CLOSED SYSTEM ALSO HAD A LEAK ¿ NO THE CHEMOLOCK PIECES BEHAVING AS USUAL. CHEMO LIKELY LEAKING OUT THE SIDE OF THE CRACKED SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665876 ↗
• MalfunctionNov 26, 2025Material Integrity Problem; Material Integrity Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656145 ↗
• MalfunctionNov 7, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303310 LOT # 5069180   VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. MY PHARMACY TECHNICIAN WAS DRAWING UP A DOSE OF INJECTABLE INTO A 20CC BD SYRINGE AND FLUID STARTED LEAKING OUT THE SIDE OF THE SYRINGE. UPON CLOSE INSPECTION, IT WAS DISCOVERED THAT THERE WAS A SMALL CRACK IN THE BARREL OF THE SYRINGE. THE PREPARATION WAS DISCARDED AND NEW SUPPLIES AND DRUG WERE OBTAINED. THERE WAS NO HARM TO THE PATIENT, ONLY WASTED DRUG FOR THE PHARMACY. ITEM# 303310 BATCH# 5069180 CUSTOMER RESPONSE ON 24-OCT-2025: THE SAMPLE IS NO LONGER AVAILABLE. IT WAS INADVERTENTLY DISCARDED BY OUR CLEANING STAFF AFTER SEVERAL WEEKS OF SITTING ON MY DESK. I DO HAVE A PHOTO - PLEASE SEE THE ATTACHED IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501576 ↗
• MalfunctionOct 22, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361163 ↗
• MalfunctionSep 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303310. BATCH # 5069190. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM: 303310. QUANTITY AFFECTED: (B)(4) EACH. SERIAL/LOT NUMBER: (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: CUSTOMER REPORTING SOME SYRINGES HAVE MOISTURE IN THEM. CUSTOMER RESPONSE ON 21-AUG-2025. PICTURE BELOW. THE HOSPITAL REPORTED THIS TO ME ON THURSDAY, AUGUST 14TH. THE CUSTOMER NO LONGER HAS THE SAMPLE, THEY DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984042 ↗
• MalfunctionAug 15, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821987 ↗
• MalfunctionJul 14, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303310. BATCH # UNKNOWN. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PHARMACY STAFF IDENTIFIED MULTIPLE QUALITY ISSUES WITH THE BD STERILE LUER-LOCK 20 ML SYRINGES, INCLUDING PARTICULATE MATTER INSIDE THE BARREL. IN SOME CASES, THE PARTICULATE MATTER WAS NOT IDENTIFIED UNTIL THE FINAL STERILE PRODUCT WAS BEING CHECKED. ONE OF THE SYRINGES FROM THE AFFECTED LOT WAS MELTED AT THE TOP AND HAD A MISSING LUER LOCK. ANOTHER CONCERN IDENTIFIED WAS INCONSISTENT VOLUME MARKINGS ON THE SYRINGE. THE AFFECTED LOTS INCLUDE 303310. ADDITIONALLY, THERE HAVE BEEN MULTIPLE REPORTS OF QUALITY AND MANUFACTURING ISSUES WITH BD SYRINGES. SOME PACKAGES WERE MISSING SYRINGES, AND OTHERS CONTAINED DAMAGED SYRINGES. REFERENCE REPORTS#: MW5171495, MW5171496.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502704 ↗
• MalfunctionJul 14, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502692 ↗
• MalfunctionJul 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468737 ↗
• MalfunctionJun 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303310, BATCH # 5015724. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE FOUND MULTI 20ML SYRINGES THAT HAVE ISSUES. WE FOUND TWO SO FAR WITH DEFECTIVE HOLE IN THE TOP AND ONE WITH WHAT APPEARS TO BE PLASTIC SHARDS IN THE SYRINGE ITSELF. THIS IS OF GREAT CONCERN FOR OUR HOSPITAL PLEASE CONTACT (B)(4) PLEASE. CUSTOMER RESPONDED ON 18-JUN. 1. THE EVENT OCCURRED ON 06-12-2025. 2- WE DO STILL HAVE 2 DEFECTIVE SYRINGES AND I AM INCLUDING (B)(4) TO HELP WITH WHERE TO MAIL THE LABEL AND WHAT DEPARTMENT IT SHOULD GO TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342267 ↗
• MalfunctionJun 2, 2025Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #303310 LOT #4319964. IV TECH NOTICED A PARTICULATE ON THE PLUNGER OF AN UNOPENED BD 20ML IV SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126509 ↗
• MalfunctionApr 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21929398 ↗
• MalfunctionApr 18, 2025Contamination; Contamination

  BASED ON INVESTIGATION RESULTS, THE REPORTED FOREIGN MATTER WAS SILICONE WHICH IS PART OF THE MANUFACTURING PROCESS, AND THE AMOUNT OF SILICONE FOUND WAS WITHIN SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865817 ↗
• MalfunctionApr 18, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 303310, BATCH#: 4023256 AND 4073843, 4044308. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE TWO 20 ML SYRINGE WITH SMALL PLASTIC PIECES SEALED INSIDE OF THE PACKAGE. ADDITIONALLY, LOOKING THROUGH THE SEQUESTERED STOCK, THEY NOTICED VERY INCONSISTENT MARKINGS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE AN ISSUE WITH PRODUCT # 303310 (STERILE LUER-LOK 20 ML SYRINGES), LOT #4044308. EVERY SYRINGE HAS HAD PARTICULATE IN IT, WITH PARTICULATE NOT SEEN IN SOME CASES UNTIL THE FINAL STERILE PRODUCT IS EVALUATED. ONE OF THE SYRINGES WE OPENED IS MELTED ON THE TOP AND IS COMPLETELY MISSING THE LUER-LOK TIP. I HAVE A SAMPLE OF A SYRINGE WITH PARTICULATE AND THE MELTED SYRINGE. I AM VERY CONCERNED THAT PARTICULATE PRODUCTS COULD BE ADMINISTERED TO PATIENTS IF THE LOT IS NOT RECALLED. WE ARE ALSO EXPERIENCING PARTICULATE ISSUES WITH LOT # 4023256 TO A LESSER DEGREE. PLEASE SHARE THE DATE OF EVENT. ISSUE DISCOVERED DURING THE COURSE OF THE WEEKEND, (B)(6) 2025. PLEASE CONFIRM WHICH LOT# IS MELTED ON THE TOP. 4044308 - PLEASE SHARE THE QUANTITY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865597 ↗
• MalfunctionApr 17, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303310 BATCH #4 261568. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED . GOOD MORNING BD TEAM, WE HAVE A TREND OF 20ML SYRINGES WITH HOLES IN THEM. PLEASE SEE BELOW. SAFER # PS-2025-059698 LOCATION **** DATE 04/01/25 REF 303310 LOT 4261568 --------------------------------------------------- CUSTOMER RESPONDED ON 09-APR DATE OF EVENT - 04/01/2025. ISSUE OBSERVED BEFORE USE / DURING USE - PINHOLE IN 20CC SYRINGE, CAUSING SODIUM CHLORIDE TO LEAK OUT OF SYRINGE. STATUS OF SAMPLE (YES/ NO) - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861652 ↗
• MalfunctionApr 10, 2025Contamination; Contamination

  IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 303310, BATCH#: 4044308 & 4023256. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE AN ISSUE WITH PRODUCT #303310 (STERILE LUER-LOK 20 ML SYRINGES), LOT #4044308. EVERY SYRINGE HAS HAD PARTICULATE IN IT, WITH PARTICULATE NOT SEEN IN SOME CASES UNTIL THE FINAL STERILE PRODUCT IS EVALUATED. ONE OF THE SYRINGES WE OPENED IS MELTED ON THE TOP AND IS COMPLETELY MISSING THE LUER-LOK TIP. I HAVE A SAMPLE OF A SYRINGE WITH PARTICULATE AND THE MELTED SYRINGE. I AM VERY CONCERNED THAT PARTICULATE PRODUCTS COULD BE ADMINISTERED TO PATIENTS IF THE LOT IS NOT RECALLED. WE ARE ALSO EXPERIENCING PARTICULATE ISSUES WITH LOT #4023256 TO A LESSER DEGREE. ADDITIONAL INFORMATION PROVIDED: PLEASE CONFIRM DID THE PARTICULATE PRESENT IN FLUID OR NON-FLUID PATH. A. IN FLUID PATH FOR THE PRODUCTS IN LOT 4044308 AND 4023256.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21814761 ↗
• MalfunctionApr 10, 2025Contamination; Contamination

  BASED ON INVESTIGATION RESULTS, THE REPORTED FOREIGN MATTER WAS SILICONE WHICH IS PART OF THE MANUFACTURING PROCESS, AND THE AMOUNT OF SILICONE FOUND WAS WITHIN SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21814759 ↗
• MalfunctionApr 8, 2025Crack; Leak/Splash

  PLASTIC SYRINGE CRACKED AS TECHNICIAN WAS DRAWING UP CHEMO MEDICATION. LEADING TO DRUG LEAKING OUT OF CLOSED SYSTEM TRANSFER SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 21798358 ↗
• MalfunctionMar 13, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL #303310, LOT #4114045, 4261566. 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. EMAIL(S) ATTACHED. WE HAVE A 20ML SYRINGE THAT HAS SPOTS INSIDE OF IT. FURTHER INFORMATION PROVIDED: ¿ 1. IN THE MEDSUN FORM MENTIONED THAT THE DATE OF THE EVENT AS ¿JAN-2025¿. COULD YOU PLEASE SPECIFY THE EXACT DATE WHEN THE REPORTED ISSUE HAPPENED? 1.9.2025 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE 3.THE MEDSUN FORM INDICATES THAT THE SAMPLE HAS BEEN ¿RETURNED TO MANUFACTURER (YES).¿ COULD YOU PLEASE CONFIRM WHETHER THE SAMPLE HAS ALREADY BEEN RETURNED TO BD? IF SO, PLEASE SHARE THE TRACKING NUMBER. 1.13 EMAILED [email protected]. 01.17 FEDEX TRK# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599722 ↗