BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® BLUNT FILL NEEDLE

    MDR report key: 14748510 · Received June 20, 2022

    Report

    Report Number
    3002682307-2022-00171
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 16, 2022
    Report Date
    July 15, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 211206 . MEDICAL DEVICE EXPIRATION DATE: 30NOV2026. DEVICE MANUFACTURE DATE: 02DEC021. MEDICAL DEVICE LOT #: 211231 . MEDICAL DEVICE EXPIRATION DATE: 30NOV2026. DEVICE MANUFACTURE DATE: 17DEC2021. MEDICAL DEVICE LOT #: 220229 . MEDICAL DEVICE EXPIRATION DATE: 31JAN2027 . DEVICE MANUFACTURE DATE: 18FEB2022. MEDICAL DEVICE LOT #: 211118. MEDICAL DEVICE EXPIRATION DATE: 31OCT2026. DEVICE MANUFACTURE DATE: 03NOV2021. MEDICAL DEVICE LOT #: 220115 . MEDICAL DEVICE EXPIRATION DATE: 31DEC2026. DEVICE MANUFACTURE DATE: 13JAN2022. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND POTENTIAL LOT NUMBERS 211206, 211231, 220229, 211118, AND 220115. THE REVIEWS DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLES WERE VISUALLY EXAMINED AND NO DEFECTS WERE OBSERVED. THE NEEDLE SAMPLES ALSO WERE USED TO PUNCTURE A TEST VIAL AND WERE SUBSEQUENTLY EXAMINED UNDER A MICROSCOPE AND NO DEFECTS WERE EXAMINED. TAKING INTO ACCOUNT THE PREVENTIVE CONTROLS IN PLACE, WE BELIEVE IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. AS A PART OF THE CANNULA INCOMING INSPECTION, VISUAL EXAMINATION, MEASUREMENTS, AND PENETRATION TESTS ARE PERFORMED. THE STOPPER CONDITIONS COULD HAVE AN IMPACT IN THIS TYPE OF ISSUE AND THE HANDLING OF THE PRODUCT MAY ALSO PLAY A ROLE. THE NEEDLE SHOULD PENETRATE THE VIAL AT A NINETY-DEGREE ANGLE TO MINIMIZE THE RISK OF CATCHING THE INTERNAL WALL OF THE VIAL STOPPER. AT THIS TIME, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® BLUNT FILL NEEDLE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THIS OCCURRED 134 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DRAWING UP A MEDICATION FROM A PIERCING AMPOULE, A PUNCHED-OUT RUBBER PARTICLE WAS DETECTED IN THE SYRINGE. LOT NUMBERS: 211206 (4 PC) 211231 (1 PC) 220229 (7 PC) 211118 (8 PC) 220115 (64 PC) *.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD® BLUNT FILL NEEDLE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THIS OCCURRED 134 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DRAWING UP A MEDICATION FROM A PIERCING AMPOULE, A PUNCHED-OUT RUBBER PARTICLE WAS DETECTED IN THE SYRINGE. LOT NUMBERS: 211206; 211231; 220229; 211118; 220115.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365743 BD® BLUNT FILL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown