BD Syringe 303134Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00382903031344), received between Aug 9, 2018 and Oct 23, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Volume Accuracy Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML S/T 200 S/C TIP BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:303134 BATCH#: UNKNOWN. RCC RECEIVED A COMPLAINT VIA EMAIL. CHC COMPLAINT REFERENCE #: (B)(4), HOSPITAL COMPLAINT REFERENCE #: (B)(4), CUSTOMER (HOSPITAL) NAME: XXX, CORRESPONDENCE LANGUAGE: ENGLISH, CAT# OF PRODUCT BEING COMPLAINED: (B)(4), DESCRIPTION OF PRODUCT: SYRINGE SLIP TIP 10CC 200EA/BX 2BX/CA, LOT OR S/N: UNKNOWN, COMPLAINT CATEGORY: DAMAGED / BROKEN, INCIDENT DATE: (B)(6) 2025, HOSPITAL COMPLAINT REFERENCE #: (B)(4). DETAILS OF COMPLAINT (REPORTED ISSUE): "A FULL 10ML WAS DRAWN OUT, AND WHEN THE SYRINGE WAS INSERTED INTO THE SIDE PORT AGAIN TO CHECK IF EXTRA FLUID/AIR REMAINED, THE TIP OF THE SYRINGE BROKE OFF INSIDE THE PORT AND COULD NOT BE REMOVED. SINCE THE FULL 10ML HAD BEEN DRAWN OUT AND VISUALIZED, THE FOLEY WAS THEN REMOVED WITH EASE, AND UPON VISIBLE INSPECTION, NO FLUID REMAINED INSIDE THE BALLOON." ADDITIONAL INFORMATION WILL BE SENT VIA SEPARATE EMAIL. COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS HEALTH CANADA BEEN INFORMED? UNKNOWN QTY AFFECTED: 1 EA SAMPLES A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366111 ↗
• MalfunctionFeb 3, 2025Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300307 ↗
• MalfunctionDec 12, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD SYRINGE 10ML S/T 200 S/C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THE PATIENT DID NOT RECEIVE THE FULL DOSE OF CHEMOTHERAPY BUT WAS UNHARMED COULD YOU PLEASE CONFIRM IF SYRINGE LOT: 4078418 IS ALSO EXPERIENCING LEAKAGE ISSUES? LEAKS HAVE BEEN REPORTED WITH MULTIPLE SIZES OF SPINAL NEEDLES AND IT IS UNKNOWN IF ALL THESE SYRINGES WERE FROM THE SAME LOT DURING THESE EVENTS. COULD YOU PLEASE SPECIFY THE EXACT LOCATION WHERE THE LEAK OCCURRED ON THE PRODUCT? LEAKING OCCURS FROM THE HUB OF THE SPINAL NEEDLE, AROUND THE SLIP-TIP SYRINGE. CLINICIANS STATE THAT THEY HAVE TO FORCEFULLY PRESS THE SLIP TIP SYRINGE INTO THE HUB OF THE NEEDLE TO PREVENT LEAKING, AND THAT THIS AMOUNT OF FORCE IS GREATER THAN THEY HAVE HAD TO USE TO ACHIEVE A SECURE CONNECTION PRIOR TO THESE EVENTS. CUSTOMER RESPONSE ON (B)(6) 2024. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT (MM-DD-YYYY) FOR LOT#: 4078418? A. 10-23-2024. COULD YOU PLEASE CONFIRM THE TYPE OF HAZARDOUS DRUG (CHEMO/RADIATION) OR PROVIDE THE NAME OF THE DRUG THAT CAUSED C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912378 ↗
• MalfunctionDec 10, 2024Leak/Splash; Leak/Splash

  MATERIAL#: 303134, BATCH#: 4078418. IT WAS REPORTED THAT THE BD SYRINGE 10ML S/T 200 S/C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THE PATIENT DID NOT RECEIVE THE FULL DOSE OF CHEMOTHERAPY BUT WAS UNHARMED. COULD YOU PLEASE CONFIRM IF SYRINGE LOT: 4078418 IS ALSO EXPERIENCING LEAKAGE ISSUES? LEAKS HAVE BEEN REPORTED WITH MULTIPLE SIZES OF SPINAL NEEDLES AND IT IS UNKNOWN IF ALL THESE SYRINGES WERE FROM THE SAME LOT DURING THESE EVENTS. COULD YOU PLEASE SPECIFY THE EXACT LOCATION WHERE THE LEAK OCCURRED ON THE PRODUCT? LEAKING OCCURS FROM THE HUB OF THE SPINAL NEEDLE, AROUND THE SLIP-TIP SYRINGE. CLINICIANS STATE THAT THEY HAVE TO FORCEFULLY PRESS THE SLIP TIP SYRINGE INTO THE HUB OF THE NEEDLE TO PREVENT LEAKING, AND THAT THIS AMOUNT OF FORCE IS GREATER THAN THEY HAVE HAD TO USE TO ACHIEVE A SECURE CONNECTION PRIOR TO THESE EVENTS. CUSTOMER RESPONSE ON (B)(6) 2024. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT (MM-DD-YYYY) FOR LOT#: 4078418? A. 10-23-2024. COULD YOU PLEASE CONFIRM THE TYPE OF HAZARDOUS DRUG (CHEMO/RADIATION) OR PROVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898533 ↗
• MalfunctionDec 5, 2024Break; Break

  MATERIAL: 304134, BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL BNS HAD TIP BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. MEDLINE COMPLAINT#: (B)(4), DEFECT DESCRIPTION: SYRINGE BROKE, MEDLINE PART#: 23119, PRODUCT DESCRIPTION: SYR CNTRL 10ML L/LIT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL BNS TIP BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VENDOR PART#: 304134, LOT#: UNKNOWN, DATE REPORTED: 10/11/2024, SAMPLE RECEIVED: NO, RESPONSE NEEDED: SUMMARY OF FINDINGS AND CORRECTIVE ACTION -- INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 1423395-2024-00494. ADDITIONAL INFORMATION PROVIDED: 1. KINDLY PROVIDE THE BATCH/LOT NUMBER OF THE PRODUCT. UNKNOWN. 2. KINDLY PROVIDE THE DATE OF EVENT. 10/11/2024. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO MEDICAL INTERVENTION OR INJURY. 4. PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? SAMPLE IS NOT AVAILABLE; WAS NOT RETURNED. 5. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? THE ADAPTER TIP IS BR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853005 ↗
• MalfunctionDec 5, 2024Defective Component; Defective Component

  MATERIAL: 304134 BATCH#: UNKNOWN IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL BNS PLUNGER ROD WAS BROKEN / DAMAGED.. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED MEDLINE COMPLAINT #: 200639466 DEFECT DESCRIPTION: SYRINGE BROKE MEDLINE PART #: 23119 PRODUCT DESCRIPTION: SYR CNTRL 10ML L/L VENDOR PART #: 304134 LOT #: UNKNOWN DATE REPORTED: 10/11/2024 SAMPLE RECEIVED: NO RESPONSE NEEDED: SUMMARY OF FINDINGS AND CORRECTIVE ACTION -- INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 1423395-2024-00494 ADDITIONAL INFORMATION: 1. KINDLY PROVIDE THE BATCH/LOT NUMBER OF THE PRODUCT. UNKNOWN 2. KINDLY PROVIDE THE DATE OF EVENT. 10/11/2024 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO MEDICAL INTERVENTION OR INJURY 4. PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? SAMPLE IS NOT AVAILABLE; WAS NOT RETURNED 5. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? THE ADAPTER TIP IS BREAKING OFF OF THE SYRINGE AND THE PLUNGER IS OFF CENTER AND COMES OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852895 ↗
• MalfunctionNov 21, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751082 ↗
• MalfunctionApr 16, 2024Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML S/T 200 S/C HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGES WITHOUT GRADUATION MARKING.". VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I HOPE YOU ARE WELL. I AM (B)(6), SQE FROM MEDTRONIC. THIS E-MAIL IS TO NOTIFY YOU ABOUT A QUALITY EVENT DETECTED IN OUR MANUFACTURING PROCESS. THE DETAILS ARE LISTED IN THE TABLE BELOW. MDT PART NUMBER. DESCRIPTION. MDT LOT. IMPACTED QTY. SUPPLIER LOT. PO. ISSUE. M728424B001. SYRINGE 10 ML. 0012051061; 0012173819. (B)(4) EA. (B)(4) EA. 3206175 (B)(4) SYRINGES WITHOUT GRADUATION MARKING. PICTURES OF THE NONCONFORMANCE: [CID:(B)(4)]. PLEASE HELP US WITH THE FOLLOWING: *MITIGATION ACTIVITIES: INCLUDES REVIEW OF STOCK/WIP, LOT NUMBER WITHOUT THE NONCONFORMANCE ON THE NEXT SHIPMENT TO MEDTRONIC AND CONFIRM IF THE SCOPE IS ONLY FOR THE MATERIAL REPORTED OR IF THERE COULD BE ADDITIONAL LOTS IMPACTED BY THIS NONCONFORMANCE. PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS. THANKS IN ADVANCE! (B)(6). SUPPLIER QUALITY ENGINEER / (B)(4). ADDITIONAL INFORMATION PROVIDED ON 04/09/2024: 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122448 ↗
• MalfunctionApr 16, 2024Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML S/T 200 S/C HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGES WITHOUT GRADUATION MARKING.". VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I HOPE YOU ARE WELL. I AM (B)(6), SQE FROM MEDTRONIC. THIS E-MAIL IS TO NOTIFY YOU ABOUT A QUALITY EVENT DETECTED IN OUR MANUFACTURING PROCESS. THE DETAILS ARE LISTED IN THE TABLE BELOW. MDT PART NUMBER. DESCRIPTION. MDT LOT. IMPACTED QTY. SUPPLIER LOT. PO. ISSUE. M728424B001. SYRINGE 10 ML.. 0012051061. 0012173819. (B)(4) EA. (B)(4) EA. (B)(4). (B)(4). SYRINGES WITHOUT GRADUATION MARKING PICTURES OF THE NONCONFORMANCE: [CID:E4BA0717-B935-4107-A7C8-9F727166D06C] PLEASE HELP US WITH THE FOLLOWING: *MITIGATION ACTIVITIES: INCLUDES REVIEW OF STOCK/WIP, LOT NUMBER WITHOUT THE NONCONFORMANCE ON THE NEXT SHIPMENT TO MEDTRONIC AND CONFIRM IF THE SCOPE IS ONLY FOR THE MATERIAL REPORTED OR IF THERE COULD BE ADDITIONAL LOTS IMPACTED BY THIS NONCONFORMANCE. PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS. THANKS IN ADVANCE! (B)(6). SUPPLIER (B)(4) . ADDITIONAL INFORMATION PROVIDED ON 04/09/2024: 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122447 ↗
• MalfunctionJan 16, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD SYRINGE BARREL/FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ORDERED A BD SYRINGE THOUGH MEDLINE THAT WE BELIEVE FALLS UNDER THIS ISSUE. WE HAVE A VERGE REPORTS ON THE DEVICE BREAKING AND SPRAYING BLOOD DURING A DRAW. I HAVE INCLUDED THE BD ALSO IF THEY WOULD DO THE QA VS. MEDLINE." ADDITIONAL INFORMATION RECEIVED ON 01/08/2024: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO. 2. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES. 3. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? NO. 4. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? NO. 5. HOW WAS TREATMENT COMPLETED FOR CUSTOMER? GRABBED ANOTHER SYRINGE. 6. PATIENT STATUS?N/A. 7. ANY PICTURE OF THIS COMPLAINT NO. 8.PLEASE EXPLAIN ELABORATE ISSUE? WHEN USING A 10 ML SLIP TIP BD SYRINGE TO DRAW A BLOOD SAMPLE FROM IV START, THERE WAS A HOLE IN THE SYRINGE CHAMBER STRAIGHT FROM PACKAGE. THIS WAS NOT NOTICED UNTIL BLOOD STARTING COMING FROM THE HOLE. 9. DATE OF EVENT? 12/15.2023. 10.PHYSICAL AVAILABLE/NOT AVAILABLE? NO. 12. CUSTOMER ADDRESS? (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522489 ↗
• MalfunctionFeb 6, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ SLIP TIP SYRINGES WITHOUT NEEDLES EXPERIENCED FOREIGN MATTER CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8312620 ↗
• MalfunctionAug 9, 2018Problem with Sterilization; Component Missing

  IT WAS REPORTED THAT BD¿ SLIP TIP SYRINGES WITHOUT NEEDLES HAD STERILE BREACH DUE TO A BROKEN SEAL ON THE PACKAGING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7766262 ↗