BD Twinpak 303391Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903033911), received between May 7, 2019 and Apr 23, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/TWINPAK DEVICE BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303391 LOT # 4326390.   VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT CODE SKU:0723303391 PRODUCT DESCRIPTION BRAND NAME:SYRINGE COMBO 3 CC TWIN PAK WHEN PROBLEM WAS NOTICE: DURING USE STERILIZATION WRAP: INCIDENT DISCOVERED DURING PATIENT CARE:YES NATURE OF PATIENT CARE:UNKNOWN QUANTITY: (B)(4). UOM: BOX 2 LOT: 4326390 DATE OF EVENT: 4/1/2025 12:00:00 AM INCIDENT DETAILS: SYRINGE IS CRACKED. LEAKING WHILE IN USE. NO NOTICEABLE DAMAGE TO THE PACKAGE. WAS PATIENT OR END-USER INJURED: NO INJURY DETAILS: WAS MEDICAL TREATMENT REQUIRED:NO TREATMENT DETAILS: PATIENT CURRENT STATUS: UNKNOWN HAS THE FACILITY FILED A REPORT WITH HEALTH AUTHORITY(IES)?: NO IS PHOTO AVAILABLE: YES ATTACH PHOTO: TWINPAK.JPG IS SAMPLE AVAILABLE:YES SAMPLE USED/UNUSED: UNUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896328 ↗
• MalfunctionDec 16, 2024Crack; Crack

  MATERIAL: 303391 , BATCH#: 4075191. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/TWINPAK DEVICE BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CUSTOMER REPORTS FAILURE WITH BD 3 ML SYRINGE, BD TWINPACK REF:(B)(4)., LOT NUMBER: 4075191, EXPIRATION: 02/28/2029. CUSTOMER VERBATIM: SITUATION: ON (B)(6), DURING THE ADMINISTRATION OF CRYSVITA, THE LVN PREPARED THE INJECTION IN TWO 3 ML BD TWIN-PACK SYRINGES. DURING THE ADMINISTRATION, THE LVN NOTICED THAT A PARTIAL DOSE OF THE INJECTION LEAKED OUT. LVN WITHDREW THE SYRINGE AND UPON DETAILED INSPECTION, IT WAS FOUND THAT THE SYRINGE HAD A SMALL CRACK BETWEEN THE 0.5 AND 1.5ML BLACK LINES. THE SECOND SYRINGE WAS INSPECTED AND WAS NOT FAULTY, AND THE PATIENT RECEIVED THE FULL 1.5 ML DOSE FROM IT (FULL DOSE FOR PATIENT WOULD HAVE BEEN 3.0ML BETWEEN THE TWO INJECTIONS). BACKGROUND: ¿ BD 3 ML SYRINGE, BD TWINPACK (REF: (B)(4)., LOT NUMBER: 4075191, EXPIRATION: 02/28/2029). ¿ THE DEFECTIVE SYRINGE WAS NOT NOTICED BEFORE ADMINISTERING THE MEDICATION. ASSESSMENT: ¿ THE PATIENT MAY HAVE RECEIVED LESS THAN HALF OF THE INTENDED FIRST DOSE DUE TO THE LEAKING SYRINGE. ¿ THE OTHER SYRINGE FUNCTIONED PROPERLY,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20947872 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED WHILE USING BD TWINPAK¿ DUAL CANNULA DEVICE WITH 3 ML SYRINGE THE NEEDLE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED BROKEN FOUND BY A NURSE. IT WAS NOT USED ON A PATIENT. IT BROKE OFF. I CANNOT EXPLAIN ANY FURTHER. DATE OF INCIDENT IS AUG. 1, 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599784 ↗
• MalfunctionMay 19, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT 3 SYRINGE 3ML LL W/TWINPAK DEVICE WERE FOUND TO BE DAMAGED. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT 3 SYRINGES WERE CRACKED ON THE SIDE. PER COMPLAINT DETAILS RECEIVED: HAVING AN ISSUE WITH 3 SYRINGES CRACKED ON SIDE DURING A RADIOLOGY PROCEDURE, 3 TIMES OUR DI STAFF HAVE HAD 3 DIFFERENT SYRINGES BREAK: REF # (B)(4), THIS HAS BEEN REPORTED TO HEALTHTRUST IN THE GPO MEMBER SUPPORT PORTAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847801 ↗
• MalfunctionSep 13, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 3ML SYRINGE WITH BD TWINPAK EXPERIENCED DEVICE DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303391, BATCH NO: 9101699. EVENT DESCRIPTION: QUANTITY AFFECTED: 1 BX . REPORTED ISSUE: ABOUT 30 OF THE SYRINGES HAD THE NEEDLE BROKEN OFF IN THE PACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9042598 ↗
• MalfunctionMay 7, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE OF THE BD 3ML SYRINGE WITH BD TWINPAK THE NURSE NOTICED A FOREIGN SUBSTANCE INSIDE OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF OUR ER NURSES NOTICED A FOREIGN SUBSTANCE IN THE SYRINGE SHE WAS ABOUT TO USE ON A PATIENT. SO FAR, THIS IS AN ISOLATED INCIDENT, HOWEVER WE ARE STILL IN THE PROCESS OF EXAMINING THE REST OF OUR STOCK THROUGHOUT THE HOSPITAL."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8587095 ↗