BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 13122378 · Received December 30, 2021

    Report

    Report Number
    8041187-2021-01085
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    November 19, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    GAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 210634. THE REVIEW 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. AS THE LOT NUMBER INVOLVED IN THE SECOND EVENT WAS UNKNOWN, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE REPORTED LOT NUMBER WERE OBTAINED FOR FURTHER EVALUATION. THE RETAINED NEEDLES WERE EXAMINED AND NO ISSUES WERE FOUND. CONSIDERING THE PROVIDED FEEDBACK, WE UNDERSTAND THAT AN ISSUE OF BROKEN HUB COMPONENT TOOK PLACE; HOWEVER, BASED ON THE INVESTIGATION RESULTS, AN EXACT MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED. WE CANNOT DISCARD THAT THE HANDLING OF THE PRODUCT MAY HAVE HAD A POTENTIAL IMPLICATION IN THIS REPORTED INCIDENT. IT IS IMPORTANT THAT THE NEEDLE PUNCTURES THE STOPPER AT A NINETY-DEGREE ANGLE DURING USE.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 210634. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-06-16. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 210634. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-06-16. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD¿ BLUNT FILL NEEDLE FROM LOT 210634, AND AN UNSPECIFIED NUMBER OF NEEDLES FROM AN UNSPECIFIED LOT BROKE OFF WHEN ATTEMPTING TO PUNCTURE THROUGH THE RUBBER STOPPER OF THE ANTIBIOTIC VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE NEEDLE BROKE OFF AT ITS BASE WHEN IT PRICKED INTO THE RUBBER STOPPER OF A VIAL OF ANTIBIOTICS. EVENT#1 THIS MALFUNCTION IS REPORTED AS VERY REGULAR WITH THIS DEVICE FROM DIFFERENT BATCHES. EVENT#2"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD¿ BLUNT FILL NEEDLE FROM LOT 210634, AND AN UNSPECIFIED NUMBER OF NEEDLES FROM AN UNSPECIFIED LOT BROKE OFF WHEN ATTEMPTING TO PUNCTURE THROUGH THE RUBBER STOPPER OF THE ANTIBIOTIC VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE NEEDLE BROKE OFF AT ITS BASE WHEN IT PRICKED INTO THE RUBBER STOPPER OF A VIAL OF ANTIBIOTICS. EVENT#1 THIS MALFUNCTION IS REPORTED AS VERY REGULAR WITH THIS DEVICE FROM DIFFERENT BATCHES. EVENT#2".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD¿ BLUNT FILL NEEDLE FROM LOT 210634, AND AN UNSPECIFIED NUMBER OF NEEDLES FROM AN UNSPECIFIED LOT BROKE OFF WHEN ATTEMPTING TO PUNCTURE THROUGH THE RUBBER STOPPER OF THE ANTIBIOTIC VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE NEEDLE BROKE OFF AT ITS BASE WHEN IT PRICKED INTO THE RUBBER STOPPER OF A VIAL OF ANTIBIOTICS. EVENT#1 THIS MALFUNCTION IS REPORTED AS VERY REGULAR WITH THIS DEVICE FROM DIFFERENT BATCHES. EVENT#2".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021188 BD¿ BLUNT FILL NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BECTON DICKINSON, S.A. SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown