N/A 305181Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00382903051816), received between Nov 27, 2017 and May 25, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (12 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2026Contamination

  IT WAS REPORTED BY CUSTOMER THAT BLACK SPOTS FOUND ON MULTIPLE NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25272398 ↗
• MalfunctionJan 8, 2026Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007883 ↗
• MalfunctionDec 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803668 ↗
• MalfunctionDec 4, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD NEEDLE 18X1IN BLUNT FILL HAD EPOXY ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305181, LOT#: 5174823. RCC RECEIVED A COMPLAINT VIA EMAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23723472 ↗
• MalfunctionMay 14, 2025Defective Component; Defective Component

  MATERIAL#: 305181, LOT#: 4247037. IT WAS REPORTED BY CUSTOMER THAT CORING NEEDLES. HAVE YOU RECEIVED ANY FEEDBACK FROM OTHER INSTITUTIONS? I WATCHED A TRAINING VIDEO AND IT LOOKED LIKE IT GOES 90 DEGREES IN (I'M USED TO 45 DEGREES ANGLE WITH REGULAR NEEDLES), SO DO YOU HAVE ANY OTHER SUGGESTIONS TO MINIMIZE THE CORING?

  Patient problems: Insufficient Information

  MAUDE report 22019292 ↗
• MalfunctionMay 7, 2025Defective Component; Defective Component

  MATERIAL: 305181 BATCH#: 4116544 . IT WAS REPORTED BY THE CUSTOMER THAT HAVE ANOTHER INCIDENT WITH DRAWING UP LIDOCAINE HCL 1% WITH THE BD BLUNT NEEDLES. I HAVE ANOTHER INCIDENT WITH DRAWING UP LIDOCAINE HCL 1% WITH THE BD BLUNT NEEDLES. THE INCIDENT OCCURRED (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21977207 ↗
• MalfunctionMay 5, 2025Defective Component; Defective Component

  MATERIAL: 305181 BATCH#: 4116544 IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A BLACK SPECK IN THE VIAL FROM THE RUBBER CORING WHEN DRAWING UP THE MEDICATION. VERBATIM: ¿EVENT: WE HAD TWO DIFFERENT CLINICIANS DRAW UP LIDOCAINE XXX (MULTIDOSE VIAL) 1% LOT # HN6899 EXP 11/1/25. AFTER EACH CLINICIAN DREW UP THE LIDOCAINE AT A 90 % ANGLE WITH TWO DIFFERENT VIALS, THERE WAS A BLACK SPECK IN THE VIAL FROM THE RUBBER CORING WHEN DRAWING UP THE MEDICATION. A BD BLUNT FILL NEEDLE 18GX1IN WAS USED TO DRAW UP THE MEDICATION. LOT # 4116544 EXP 8/31/29.¿ ADDITIONAL INFORMATION LOT # 4116544 EXP 8/31/29 BD BLUNT FILL NEEDLE 18G 1IN NO PATIENT HARM OR INJURY - RUBBER PARTICLE IN THE MEDICATION AFTER PUNCTURING THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960549 ↗
• MalfunctionMar 4, 2025Defective Component; Defective Component

  MATERIALS: 305181 BATCH#: UNKNOWN. VERBATIM: CORING OF STOPPER WITH INTRODUCTION OF FOREIGN MATTER INTO THE VIAL WHEN USING THE BLUNT FILL NEEDLE ON A VIAL OF SOLUMEDROL. ADDITIONAL INFORMATION HERE IS INFORMATION FROM THE NURSING STAFF, IN WHICH THIS OCCURRED WITH 2 DIFFERENT NURSES AND ONLY SOLU MEDROL: WHEN I WENT UP TO LOOK AT IT, THE NEEDLE WAS A BD BLUNT FILL NEEDLE ¿ FILTER 18G X 1 ½. I DON¿T HAVE ANY LOT OR EXPIRATION INFORMATION FOR THE NEEDLE. I RECOMMENDED THAT HER STAFF USE A NEEDLE WITH A BEVEL INSTEAD OF THE BLUNT TIP TO SEE IF THAT MADE A DIFFERENCE, BUT I RECEIVED ANOTHER MESSAGE FROM SHANNA THAT THE ISSUE WAS STILL HAPPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513681 ↗
• MalfunctionFeb 28, 2025Defective Component; Defective Component

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21492260 ↗
• MalfunctionApr 30, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305181 BATCH#: 3299661 IT WAS REPORTED BY CUSTOMER THAT BLUNT FILL NEEDLE IS TOO SHARP AND HAS CAUSED CORING OF THE VIAL. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. BLUNT FILL NEEDLE IS TOO SHARP AND HAS CAUSED CORING OF THE VIAL.

  Patient problems: Insufficient Information

  MAUDE report 19215594 ↗
• MalfunctionFeb 12, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION RECEIVED. GOOD MORNING, WE HAVE RECEIVED IN THE AREA OF SURVEILLANCE OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES, NOTIFICATION FROM THE HEALTH PROFESSIONAL SERGIO GANBO (WITH EMAIL [email protected] ), REGARDING AN INCIDENT WITH THE MEDICAL DEVICE BD BLUNT FILL NEEDLE, MODEL 18G X 1 TW (1.2MM X 25 MM), SERIAL NUMBER UNKNOWN, LOT NUMBER 3086629, OCCURRED ON (B)(6) 2024, IN THE C.S SEVERO OCHOA, GIJÓN, ASTURIAS. THE INFORMATION PROVIDED IS AS FOLLOWS: DESCRIPTION OF THE INCIDENT: THE MEDICATION LOADING NEEDLE DESCRIBED IS NOT SAFE FOR MEDICATION PREPARATION AS ALTHOUGH IT MINIMISES THE RISK OF PUNCTURE, THE BLUNT TIP REQUIRES EXERTING MORE FORCE TO PIERCE THE VIALS WITH THE RISK OF MICROPARTICLES BEING RELEASED FROM THE PLASTIC RUBBER PROTECTING THE VIAL INTO THE DILUTION. OTHER COMMENTS: ADMINISTERING A SOLUTION OF MEDICATION WITH PLASTIC OR GLASS PARTICLES FROM THE VIALS. ON THE OTHER HAND, THE FOLLOWING INFORMATION IS REQUESTED: INCIDENTS AND/OR COMPLAINTS THAT HAVE OCCURRED IN SPAIN OF WHICH YOU HAVE HAD KNOWLEDGE RELATED TO THE PRODUCT. IF THIS PRODUCT HAS BEEN INVOLVED IN AN FSCA. UNITS OF THE AFOREMENTIONED PRODUCT DI

  Patient problems: Insufficient Information

  MAUDE report 18684485 ↗
• MalfunctionNov 9, 2023Defective Component; Device Contamination with Chemical or Other Material; Defective Component; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 18104007 ↗
• MalfunctionSep 22, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE BD¿ BLUNT FILL NEEDLE WITH SYRINGE CAUSED VISIBLE CORING IN 7 DAPTOMYCIN VIALS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TODAY WE DID A SMALL TRIAL USING THE BD BLUNT FILL NEEDLES (18G X 1 INCH REF (B)(4); LOT 3086627 EXP 5/31/28). I REVIEWED THE APPROPRIATE TECHNIQUE WITH OUR PHARMACY TECHNICIAN. SHE THEN RECONSTITUTED 20 VIALS OF DAPTOMYCIN USING THEM. OF THE 20 VIALS WE SAW VISIBLE CORES IN 5 OF THEM. NONE WERE SENT OUT TO PATIENTS. WE ALSO WITHDREW DOSES FROM SEVERAL OTHER DAPTOMYCIN VIALS THAT HAD BEEN RECONSTITUTED THE PREVIOUS DAY AND WERE STORED IN THE FRIDGE. NONE OF THE VIALS CONTAINED A VISIBLE CORE. HOWEVER WHEN WE USED THE BLUNT FILL NEEDLES TO WITHDRAW DOSES WE HAD VISIBLE CORES IN 7 OF THE FINAL DOSE SYRINGES. WE THEN FILTERED THEM SO WE COULD USE THE MEDICATION. AT THIS POINT THE BLUNT FILL NEEDLES DON?T SEEM TO BE WORKING TO PREVENT CORING OF THESE VIALS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799926 ↗
• MalfunctionAug 7, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED WHILE USING BD® BLUNT FILL NEEDLE 18 G X 1 IN THERE WAS A CLOG THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: OUR CUSTOMER COMPLAINS THAT THE CANNULA IS NOT CONTINUOUS / CANNULA DOES NOT PASS THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477353 ↗
• MalfunctionFeb 20, 2023Contamination; Contamination

  IT WAS REPORTED THAT CORING OCCURRED WHEN THE BD¿ BLUNT FILL NEEDLE WAS USED TO DRAW UP PROPOFOL FROM THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE EXPERIENCED CORING WITH OUR BLUNT FILL NEEDLE WHEN DRAWING UP PROPOFOL. MULTIPLE INCIDENTS HAVE OCCURRED - ALL WITH PROPOFOL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401953 ↗
• MalfunctionFeb 20, 2023Contamination; Contamination

  IT WAS REPORTED THAT 2 BD¿ BLUNT FILL NEEDLES WITH SYRINGE CAUSED CORING TO OCCUR IN THE MEDICATION VIAL WHILE DRAWING UP PROPOFOL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE CRNA'S ARE DRAWING UP ONLY PROPOFOL THEY ARE FINDING CORING OF THE STOPPER IN THE SYRINGE. AT FIRST THIS HAD HAPPENED WITH THE MYCO 18 GAUGE BLUNT SO WE MOVED TO THE BD BLUNT AND NOW THE SAME ISSUE HAS HAPPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401908 ↗
• MalfunctionFeb 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD¿ BLUNT FILL NEEDLE WITH SYRINGE CAUSED CORING TO OCCUR IN THE MEDICATION VIAL WHILE DRAWING UP PROPOFOL. THIS OCCURRED WITH 2 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED OUR NEW BD NEEDLES AND I SWAPPED THEM OUT ON (B)(6) 2023... CORING WITH NEW NEEDLES FROM BD... THEY STATED THIS ONLY HAPPENS WITH PROPOFOL. IT OCCURS BECAUSE OF HOW THE STOPPER IS MANUFACTURED AND DOES NOT OCCUR WITH OTHER MEDICATIONS THAT THEY DRAW UP WITH THESE BLUNT FILL NEEDLES. ONE OF THE CRNA¿S REPORTED THAT THIS HAPPENED AT LEAST 1 OTHER TIME THIS MORNING, POSSIBLY MORE. THE CORES ARE SMALL AND PROPOFOL EASILY CONCEALS THE CORE IF YOU ARE NOT LOOKING FOR IT. THEY ALSO STATED THIS HAPPENS ANYWHERE THESE LARGE BORE METAL NEEDLES ARE IN USE. ONE OF THEM TRIED USING A FILTER NEEDLE TO DRAW UP PROPOFOL. THE FILTER NEEDLE STILL CREATED A CORE WHICH REMAINED IN THE VIAL BECAUSE THE FILTER NEEDLE PREVENTED IT FROM MOVING INTO THE SYRINGE, BUT THIS WOULD BE A VERY INEFFICIENT WAY TO DRAW UP PROPOFOL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16317093 ↗
• MalfunctionJan 20, 2023Contamination; Contamination

  IT WAS REPORTED WHILE USING BD¿ BLUNT FILL NEEDLE 18 G FOREIGN MATTER WAS FOUND AND THE MEDICATION BECAME DISCOLORED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOTICED THAT WHEN THE MEDICATION WAS DRAWN UP, THE MEDICATION TURNED A LIGHT ORANGE COLOR. THE MEDICATION IN THE VIAL WAS INITIALLY CLEAR. THE INSIDE OF THE BLUNT TIP NEEDLE THAT SHE USED TO DRAW UP THE MEDICATION, THERE WAS A BLACK MATERIAL (ALMOST LOOKING LIKE MOLD OR INK OF SOME SORT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213381 ↗
• MalfunctionOct 29, 2022Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED WHILE USING BD NEEDLE 18X1IN BLUNT FILL FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THE NURSE WAS PREPARING THE RECONSTITUTION OF A DRUG AND TOOK SALINE WITH A NEEDLE AND SYRINGE. SHE NOTICES THAT THE SALINE IN THE SYRINGE IS TURNING RED. SHE CALLS ONE OF HER COLLEAGUES TO CHECK. SHE DECIDES TO REDO HER PREPARATION USING NEW DEVICES WHICH SHE CHECKS CAREFULLY BEFORE USE. SHE THEN NOTICES THAT THE NEEDLE STILL IN THE BAG THAT SHE IS ABOUT TO USE CONTAINS A LIQUID AND DRIED TRACES. AGAIN THE SYRINGE TURNS RED. THE STRIP TEST REVEALS THE PRESENCE OF BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695589 ↗
• MalfunctionMay 23, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD¿ BLUNT FILL NEEDLE 18 G X 1 IN FOREIGN MATTER, POSSIBLY RUST, WAS FOUND IN THE FLUID PATHWAY THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS I CHANGE THE PUMP TO TOP UP THE SYRINGE, THE CONTENTS ARE TURNING BROWN. LOOKING AT THE NEEDLE I SEE THAT THE GUARD IS FILLED WITH A DARK "CLOT". I PUSH THE CONTENTS OF THE SYRINGE BACK ONTO A COMPRESS AND BROWN RESIDUE COMES OUT OF THE GUARD (LOOKS LIKE RUST)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470698 ↗
• MalfunctionApr 26, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED BD¿ BLUNT FILL NEEDLE 18 G X 1 IN. HAD DAMAGED PACKAGING, POTENTIALLY IMPACTING PRODUCT STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PIECES OF PLASTIC WERE FOUND TO BE TORN FROM THE PLASTIC SURFACE IN THE NEEDLE HEADS. THE INCIDENCE OF THE PIECES IS QUITE HIGH (ESTIMATED AT ABOUT 15% OF THE NEEDLES)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207816 ↗
• MalfunctionFeb 16, 2021Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NEEDLE 18X1IN BLUNT FILL WAS CORING AND THERE WAS FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305181, BATCH NO: UNKNOWN. IT WAS REPORTED THAT NEEDLES ARE CORING AND PLASTIC SHARDS ARE SEEN IN THE MEDICATION WITHIN THE SYRINGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11336255 ↗
• MalfunctionFeb 3, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE NEEDLE 18X1IN BLUNT FILL EXPERIENCED PACKAGING TEARS WHILE OPENING LEAVING PAPER SHARDS IN STERILE ROOM/FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305181, BATCH NO.: UNKNOWN. THE CONCERN WE HAVE WITH THIS EXACT BLUNT FILL NEEDLE IS THAT THE PAPER PACKAGING THE NEEDLES COME IN LEAVES DUST PARTICLES IN THE AIR THAT THE PLASTIC COVERS DO NOT OR IN THE CASE OF THE CARDINAL NEEDLE, NO PACKAGE AT ALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11275953 ↗
• MalfunctionJan 15, 2021Break; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE 18X1IN BLUNT FILL EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLES DO NOT ADAPT WELL TO BD PLASTIPAK SYRINGES. THE PUMPING MACHINES DO NOT ADAPT WHEN PLACED ON THE SYRINGE. THE NEEDLES DO NOT FIT WELL ON THE BD PLASTIPAK SYRINGES AND BECOME UNSUITABLE WHEN PLACED ON THE SYRINGE. THIS HAS HAPPENED ON SEVERAL OCCASIONS. THE DEVICE HAS BEEN KEPT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11181497 ↗
• MalfunctionAug 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NEEDLE 18 X 1 IN BLUNT FILL HAD FOREIGN MATTER ON THE NEEDLE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305181, BATCH NO. 9350653. IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE NEEDLE INSIDE THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 10411667 ↗