BD Twinpak 303390Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903033904), received between Oct 28, 2019 and Apr 27, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  MATERIAL # 303390. BATCH # 4142679. IT WAS REPORTED BY THE CUSTOMER THAT THE TWIN PAK NEEDLES, EACH HAVE THE SAME LOT# BUT THE OUTDATE IS VERY CLEARLY NOT THE SAME. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I NEED TO BRING THIS ISSUE TO YOUR ATTENTION. THE PRODUCT IN THE PICTURE, (B)(6) TWIN PAK NEEDLES, EACH HAVE THE SAME LOT# BUT THE OUTDATE IS VERY CLEARLY NOT THE SAME. COULD YOU PLEASE ALERT BD AND HAVE THEM PROVIDE US SOME CLARIFICATION AS TO THE CORRECT DATE? I HAVE 9 BOXES IN THE STOREROOM WITH THE EARLIER OUTDATE, AND PROBABLY. ITEM - 303390. LOT - 4142679.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915937 ↗
• MalfunctionAug 2, 2024Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error; Device Markings/Labelling Problem

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL #:303390. BATCH#:4142679. IT WAS REPORTED BY CUSTOMER THAT THERE IS A MISMATCH IN EXPIRY DATE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PLEASE OPEN A QUALITY COMPLAINT FOR THIS BD PRODUCT AT COREWELL HEALTH. ALSO, PLEASE CONFIRM THE OFFICIAL EXPIRATION DATE OF THE LOT IN QUESTION. HERE ARE THE RELEVANT EVENT AND PRODUCT DETAILS: EVENT DATE: 7-30-2024. EVENT LOCATION: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX EVENT DESCRIPTION: ¿PRODUCT WITH LOT# 4142679 HAS A 5-31-29 EXPIRATION DATE PRINTED ON THE OUTER-MOST CASE. THE 10 BOXES INSIDE THE CASE HAVE A 5-31-24 EXPIRATION DATE, AND THE INDIVIDUAL CANNULAS HAVE A 5-31-29 EXPIRATION DATE.¿ HARM TO TEAM MEMBER OR PATIENT? NO INJURY TO MY KNOWLEDGE. PRODUCT NAME: ITM-1138902 - DEVICE TWIN PAK DUAL CANNULA. PRODUCT REF: 303390. LOT NUMBER: 4142679. BD CUSTOMER ACCOUNT NUMBER: (B)(4). ACTUAL PRODUCT INVOLVED IS AVAILABLE FOR RETURN FOR EVALUATION PURPOSES ¿ PLEASE SEND SHIPPING LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19895170 ↗
• MalfunctionMay 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD TWINPAK¿ DUAL CANNULA DEVICE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CRNA FOUND A PIECE OF METAL SHAVING ATTACHED TO RED BLUNT TIP NEEDLE PORTION OF THE BD TWINPAK NEEDLE SET. THIS WAS CAUGHT BEFORE IT WAS USED TO PIERCE A MEDICATION VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899292 ↗
• MalfunctionJan 26, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD SCALE MARK SYRINGE WITH LUER-LOK TIP FOREIGN MATTER WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THIS SYRINGE BEHIND THE STOPPER WAS A LOT OF ¿POWDERY SUBSTANCE¿. SHE REMOVED THIS FROM THE PACKAGE AND DREW UP HEPARIN. WHEN SHE WENT TO RELEASE THE EXTRA AIR SHE NOTICED ALL THE POWDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251467 ↗
• MalfunctionJan 5, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD TWINPAK¿ DUAL CANNULA DEVICE PLASTIC TIP OFTEN CORES OUT A PIECE OF THE RUBBER STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLASTIC TIP OFTEN CORE OUT A PIECE OF THE RUBBER STOPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109237 ↗
• MalfunctionSep 23, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED AN UNSPECIFIED NUMBER OF BD TWINPAK¿ DUAL CANNULA DEVICES EXPERIENCED CORING OF THE RUBBER STOPPER INTO THE MEDICATION VIAL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN A LARGER 1G ANCEST VILE - PUTTING THE TWIN PACK ON A 10 ML SALINE SYRINGE AND THEN PUT IT INTO THE VILE AND MIX THE CONTENTS. THEY THEN DRAW BACK INTO THE SYRINGE TO ADMINISTRATE. WHILE THE TEAM IS PUSHING THROUGH THE RUBBER STOPPER OF THE 1 G VILE ¿ THEY ARE NOTICING PIECES OF RUBBER COMING OFF INTO THE MEDICATION. THIS HAS HAPPENED 'MORE THAN A FEW TIMES'."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470597 ↗
• MalfunctionSep 22, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD TWINPAK¿ DUAL CANNULA DEVICE EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE THE TEAM IS PUSHING THROUGH THE RUBBER STOPPER OF THE 1 G VILE ¿ THEY ARE NOTICING PIECES OF RUBBER COMING OFF INTO THE MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15468025 ↗
• MalfunctionAug 31, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BD TWINPAK¿ DUAL CANNULA DEVICE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE FACILITY REPRESENTATIVE THAT THE NEEDLE DOES NOT PIERCE THE TOP OF THE VIAL AND A PIECE OF RUBBER GOT INSIDE THE VIAL. WE HAD A SITE THAT REPORTED THAT IT CAUSED CORING AND A SMALL PIECE OF RUBBER WAS NOTED IN THE SYRINGE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393142 ↗
• MalfunctionAug 25, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CANNULA TWINPAK DEVICE HAD A DIFFICULT TIME PIERCING THE VIAL, CAUSING A PIECE OF RUBBER TO SHEAR OFF INTO THE MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLUNTS DON'T PIERCE THE TOP OF THE VIALS WELL. ON MONDAY ONE OF THE CRNA'S GOT A PIECE OF THE RUBBER IN THE VIAL." "WE HAD A SITE THAT REPORTED THAT IT CAUSED CORING AND A SMALL PIECE OF RUBBER WAS NOTED IN THE SYRINGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365070 ↗
• MalfunctionFeb 28, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ON TWO (2) OCCURRENCES FOREIGN MATTER WAS FOUND ON A BD TWINPAK¿ DUAL CANNULA BEFORE USE. THE FOLLOWING INFORMATION WAS REPORTED IN THE EVENT DESCRIPTION: IT WAS REPORTED BLACK SPECS WERE FOUND IN THE MEDICATION WHEN INSIDE THE BARREL. PER PHONE CALL: IN THEIR GI DEPARTMENT THEY DISCOVERED BLACK SPECS INSIDE THE SYRINGE WHEN DRAWING UP MEDICATION. THEY TRIED WITH ANOTHER SYRINGE WITH A DIFFERENT MEDICATION AND SAME THING OCCURRED. THEY TESTED WITH SALINE AND IT WAS CLEAN. FIRST TIME THIS HAS OCCURRED. UNSURE WHICH LOT SPECIFICALLY. CAN PROVIDE PHOTOS AND REPRESENTATIVE SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9772165 ↗
• MalfunctionOct 28, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE IN THE CANNULA TWINPAK DEVICE BROKE OFF AND PULLED OUT OF THE HUB BEFORE USE WHEN THE NURSE REMOVED IT FROM THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE RED END BROKE OFF AS THE RN TOOK IT OUT OF THE PACKAGE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9244877 ↗