BD TwinpakRecalls & reported problems across all models
Becton, Dickinson And Company · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of BD Twinpak by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between May 7, 2019 and Mar 19, 2026 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Twinpak problems
Device problems
- Labelling, Instructions for Use or Training Problem16
- Device Contamination with Chemical or Other Material10
- Break4
- Device Markings/Labelling Problem4
- Leak/Splash4
- Contamination3
- Crack3
- Packaging Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Known Impact Or Consequence To Patient5
BD Twinpak models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Twinpak 303393Needle, hypodermic, single lumen25 reports
- BD Twinpak 303390Needle, hypodermic, single lumen11 reports
- BD Twinpak 303391Needle, hypodermic, single lumen6 reports
- BD Twinpak 303392Needle, hypodermic, single lumen3 reports
Recent BD Twinpak adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Labelling, Instructions for Use or Training Problem
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640120 ↗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 17, 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 22248088 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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