BD Twinpak 303393Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00382903033935), received between Oct 1, 2019 and Sep 2, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (13 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/TWINPAK DEVICE LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 303393, BATCH#: 5065846. VERBATIM: STICKER SAYS 303393 (10CC) ON THE OUTSIDE OF THE BOX BUT IN-SIDE OF THE INDIVIDUAL EACH/PACKAGING SAYS 303392 (5CC), BUT THE PRODUCT IN-SIDE THE WRAPPER IS ACTUALLY THE 10CC. THE PRODUCT WAS DISCOVERED ON 08/08/2025 AT OUR (B)(6) HOSPITAL FIRST, THEN OUR (B)(6) HOSPITAL AFTER WE NOTIFIED THEM. WE HAVE 27 BOXES AT (B)(6) AND 45 BOXES AT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948625 ↗
• MalfunctionAug 22, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/TWINPAK DEVICE LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 303393. BATCH#: 5065846. VERBATIM: XX STICKER SAYS 303393 (10CC) ON THE OUTSIDE OF THE BOX BUT IN-SIDE OF THE INDIVIDUAL EACH/PACKAGING SAYS 303392 (5CC), BUT THE PRODUCT IN-SIDE THE WRAPPER IS ACTUALLY THE 10CC. ADDITIONAL INFORMATION PROVIDED: THE PRODUCT WAS DISCOVERED ON 08/08/2025 AT OUR (B)(6) HOSPITAL FIRST, THEN OUR (B)(6) HOSPITAL AFTER WE NOTIFIED THEM. WE HAVE(B)(4) AT (B)(6) AND (B)(4) AT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877492 ↗
• MalfunctionJul 7, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22425611 ↗
• MalfunctionJun 17, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/TWINPAK DEVICE LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 303393. BATCH#: 5065846. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT REFERENCE #: (B)(4). CORRESPONDENCE LANGUAGE: ENGLISH. CAT# OF PRODUCT BEING COMPLAINED: BD303392. DESCRIPTION OF PRODUCT: SYRINGE 5CC W/CANNULA ST INTLINK 100EA/BX 4BX/CA. LOT OR S/N: (B)(6) COMPLAINT CATEGORY: LABELLING ISSUE. REPORTABLE: NO. INCIDENT DATE: (B)(6) 2025. HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): "IT WAS BROUGHT TO MY ATTENTION THERE¿S MIS-LABEL ON THE PACKAGING FOR THE 5ML SYRINGE REF 303392. WE HAVE 7BX OF 303392 (97317) 5ML BUT INSIDE OF THE PACKAGING IS THE 303393 (60902)10ML. WE WOULD LIKE TO RETURN THESE; CAN YOU PROVIDE A CREDIT FOR THESE AND RGA PAPERWORK FOR RETURN." PLEASE NOTE: INCIDENT DATE UNKNOWN. PHOTOS WILL BE SENT VIA SEPARATE EMAIL. COMPLAINT NOTICED: PRIOR TO USE. PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: PATIENT INJURY: NO. HAS XXX BEEN INFORMED? UNKNOWN. QTY AFFECTED: (B)(4). SAMPLES AVAILABLE? NO. IS CUSTOMER REQUESTING AN RGA? NO. RETURN QTY:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248455 ↗
• MalfunctionJun 4, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/TWINPAK DEVICE LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303393. BATCH # 5065846. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. HELLO, WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO. ITEM: 303393. QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: N/A. PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE PRODUCT IN THE BOXES IS DIFFERENT PRODUCT THAN WHAT THE BOXES READ. THE OUTSIDE OF THE BOXES SAY B-D303393 BUT B-D303392 ARE THE SYRINGES INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146192 ↗
• MalfunctionJun 4, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/TWINPAK DEVICE LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303393 BATCH # 5065846. RCC RECEIVED A COMPLAINT VIA EMAIL. HELLO, WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO ITEM: 303393 QUANTITY AFFECTED: 1 BX SERIAL/LOT NUMBER: (B)(6), PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE PRODUCT IN THE BOXES IS DIFFERENT PRODUCT THAN WHAT THE BOXES READ. THE OUTSIDE OF THE BOXES SAY B-D303393 BUT B-D303392 ARE THE SYRINGES INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145763 ↗
• MalfunctionJun 3, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/TWINPAK DEVICE LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303393. BATCH # 5065846. VERBATIM: I WAS AT (B)(6) TODAY AND THIS IS WHAT THEY SHOWED ME. C#983056, SHOULD BD# 303393, BD STICKER SAYS 303393 (10CC) ON THE BOX BUT IN-SIDE PACKAGING SAYS 303392 (5CC), BUT THE PRODUCT IN-SIDE THE WRAPPER IS THE 10CC?? IT IS GETTING WORSE; THEY FOUND MORE BOXES WITH THE SAME PROBLEM TODAY. PLEASE REACH OUT TO (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138019 ↗
• MalfunctionMay 27, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092734 ↗
• MalfunctionMay 25, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082726 ↗
• MalfunctionMay 25, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082725 ↗
• MalfunctionMay 22, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/TWINPAK DEVICE LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303393 BATCH #5065846 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO ITEM: 303393 QUANTITY AFFECTED:1CS SERIAL/LOT NUMBER: (B)(6) PO : (B)(6) ARE ANY SAMPLES AVAILABLE FOR RETURN? NO REPORTED ISSUE: CUSTOMER ORDERED 10ML SYRINGES BUT INSIDE THE VENDOR BOX WAS 5ML SYRINGES. ALL 3 BOXES HAVE SAME LOT NUMBER. CUSTOMER DISPOSITION REQUEST: CUSTOMER REQUESTED TO LOG COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073555 ↗
• MalfunctionMay 22, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/TWINPAK DEVICE LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303393 , BATCH #5065846. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. ISSUE: CUSTOMER ORDERED REF 303393 BUT UPON OPENING BOX NOTICED THAT THE PRODUCT WAS LABELED REF 303392 BUT THE ACTUAL DEVICE PRESENT WAS 303393. WRONG DEVICE IN PACKAGING. LOT 5065846. PT HARM: NO. SAMPLE YES. DOE (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072362 ↗
• MalfunctionMay 13, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014473 ↗
• MalfunctionJan 2, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE BD TWINPAK HAD AN OTHER ISSUE. AS PER PHOTO, THE CAP COLOR IS DIFFERENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRESENTATION ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061329 ↗
• MalfunctionAug 15, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  MATERIAL # 303393 LOT # 4114783 IT WAS REPORTED THAT THE BD TWINPAK CAPS WERE NOT GREEN IN COLOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED DIRECT MATERIAL NAME SYRINGE, 10-ML BD TWINPAK DUAL CANNULA DEVICE VENDOR-BATCH-NO 4114783 VENDOR-MATERIAL-NO 303393 DEFECT MISSING GREEN COLORANT IN THE BPC PROTECTION CAP DEFECT QUANTITY ENTIRE BD BATCH ¿ A TOTAL OF (B)(4) PCS COUNTRY OF ORIGIN USA ON 22JUL2024, DURING THE BD SYRINGE INSPECTION AT THE SITE, THE MANUFACTURING INSPECTION TEAM OBSERVED THAT THE SYRINGE CAPS IN BD BATCH 4114783 WERE IN TRANSLUCENT WHITE COLOR, INSTEAD OF TRANSLUCENT GREEN COLOR, PER THE PURCHASING SPECIFICATION XXX AND PER THE BD PRODUCT LABELING ON THE SYRINGES¿ STERILE BARRIER SYSTEM (SBS) FOLLOW-UP: CUSTOMER RESPONSE ON JUL 31, 2024 SORRY ABOUT THE CONFUSION ON THE DEFECT DESCRIPTION IN THE TABLE IN THE REQUEST LETTER DATED 24JULY2024. THE CORRECT DESCRIPTION IS MISSING THE GREEN COLORANT IN THE BPC PROTECTION CAP. PLEASE SEE THE ATTACHED LETTER FOR THE UPDATED DEFECT DESCRIPTION IN RED. THE PICTURE OF THE DEFECTIVE CAP AND THE OTHER INFO YOU REQUESTED ARE IN THE INVESTIGATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990098 ↗
• MalfunctionAug 5, 2024Packaging Problem; Packaging Problem

  MATERIAL# 303393 BATCH# 4114783 IT WAS REPORTED THAT THE BD TWINPAK HAD A PRODUCT PACKAGING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED HI XXX ¿ PLEASE SEE BELOW COMMENT FROM XXXX WHO PURCHASES 303393. THEY NOTICED A CHANGE IN PACKAGING COLOR AND ARE HAVING ISSUES WITH INSPECTION. WE LIKELY DO NOT HAVE A QA/CNC AGREEMENT WITH THEM AND MAY NOT BE OBLIGATED TO NOTIFY NEVERTHELESS WOULD BE GOOD TO SUPPORT THEM WITH SOME RESPONSE ON THE CHANGE GIVEN THE BUSINESS WE HAVE BEEN DOING ON A REGULAR BASIS. THEY NOTED THAT THE PACKAGING OF THE MATERIAL USED TO BE CLEAR BUT NOW HAS A GREEN COLOR. ITEM -303393 LOT - 4114783 PO- 4500273006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19908692 ↗
• MalfunctionMar 11, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD TWINPAK PACKAGE SEAL INTEGRITY WAS POOR/QUESTIONABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNSEALED BD SYRINGES WITH TWINPAK DUAL CANNULA DEVICE SYSTEMS IN THE GENENTECH TNKASE KITS." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. UNSEALED BD SYRINGES WITH TWINPAK DUAL CANNULA DEVICE SYSTEMS IN THE GENENTECH TNKASE KITS. ITEM#303393.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874453 ↗
• MalfunctionFeb 14, 2024Break; Break

  MATERIAL#: 303393. LOT#: 3060712. IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE PORTION KEEPS BREAKING OFF. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE BEEN HAVING A LOT OF TROUBLE WITH OUR 10ML SYRINGE ITEM#303393 (REF#303393 . I HAVE ATTACHED PICTURES. THE NEEDLE PORTION KEEPS BREAKING OFF, OR IS BROKEN OFF. IT APPEARS TO BE THE SAME LOT (#3060712) THAT IS HAVING THIS ISSUE. JUST WONDERING IF OTHERS ARE REPORTING THIS ISSUE OR IF YOU KNOW OF A RECALL ON THIS LOT?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707367 ↗
• MalfunctionFeb 3, 2024Crack; Crack

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636976 ↗
• MalfunctionJan 12, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD TWINPAK¿ DUAL CANNULA DEVICE WITH SYRINGE HAD EXCESSIVE FOREIGN MATTER IN THE STERILE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EXCESSIVE PARTICULATES INSIDE OF THE STERILE PACKAGES"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148431 ↗
• MalfunctionJan 12, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD TWINPAK¿ DUAL CANNULA DEVICE WITH SYRINGE GTIN# WAS INCOMPLETE ON THE PACKAGING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INCOMPLETE GTIN # PRINTED ON THE STERILE PACKAGES"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148423 ↗
• MalfunctionJul 21, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 927 BD TWINPAK¿ DUAL CANNULA DEVICES WITH SYRINGE HAD FOREIGN, PARTICULATE MATTER FOUND ON THEM DURING THE KITTING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN KITTING THE BD SYRINGES INTO OUR DRUG PRODUCT PACKAGING KIT, THE HTO OPERATIONS TEAM PERFORMS A 100% VISUAL INSPECTION OF THE SYRINGES. THE TEAM RECENTLY CULLED 927 PARTICULATE DEFECTS OUT OF AN INSPECTED BATCH SIZE OF 12,900 UNITS, WHICH EXCEEDED OUR INTERNAL DEFECT ACTION LIMIT OF 5%... DEFECT CODE: PARTICULATE INSIDE OF THE STERILE PACKAGE DEFECT RATE: 7.2% (927 OUT OF 12,900 UNITS INSPECTED)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080738 ↗
• MalfunctionMay 25, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 1 BD 10ML SYRINGE WITH BD TWINPAK HAD CLOUDY WATER IN THE FLUID PATH ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED TO THE GENENTECH COMPLAINT MANAGEMENT TEAM OF A CLOUDY SWIFT IN A 10-ML BD TWINPAK DUAL CANNULA DEVICE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496968 ↗
• MalfunctionApr 28, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE SYRINGE 10ML LL W/TWINPAK DEVICE HUB WOULD NOT DETACH FROM THE VIAL OF TNKASE AND THE NEEDLE BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE REPORTER STATED THAT IN THE PROCESS OF DRAWING UP THE DOSE OF TNKASE (TENECTEPLASE) ON 03/29/2021, THE RED HUB WOULD NOT DETACH FROM THE VIAL AND THE NEEDLE BROKE OFF. THE REPORTER STATES THE TNKASE WAS DRAWN UP WITH ANOTHER NEEDLE AND THERE WAS A SLIGHT DELAY IN ADMINISTRATION OF 20 MINS BUT IT WAS GIVEN WITHIN THE TIME FRAME OF 60 MINS." "THE DRUG ADMINISTRATION PROCEDURE WAS DELAYED FOR 20 MINS IN AN EMERGENCY SETTING. TNKASE IS USED IN EMERGENCY SITUATIONS FOR USE IN THE REDUCTION OF MORTALITY ASSOCIATED WITH ACUTE MYOCARDIAL INFARCTION (AMI). TREATMENT SHOULD BE INITIATED AS SOON AS POSSIBLE AFTER THE ONSET OF AMI SYMPTOMS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742482 ↗
• MalfunctionOct 1, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING USE NEEDLE CORING OCCURRED WITH A BD SYRINGE 10ML LL W/TWINPAK DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE CORED WHEN INSERTED INTO THE VIAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9141226 ↗