BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLE

    MDR report key: 18619866 · Received January 31, 2024

    Report

    Report Number
    3002682307-2024-00015
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 8, 2024
    Report Date
    April 24, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 230716. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, THIRTY (30) UNUSED SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. TWENTY (20) OF THE SAMPLES WERE SELECTED FOR THOROUGH EXAMINATION; HOWEVER, NO SIGNS OF NEEDLE CLOGGING WERE OBSERVED. ALTHOUGH THE DEFECT COULD NOT BE CONFIRMED, BASED ON THE PROVIDED FEEDBACK, WE UNDERSTAND AN ISSUE OF CORING MAY HAVE OCCURRED, RESULTING IN A CLOGGED NEEDLE. WE WOULD LIKE TO INFORM YOU THAT NEW MATERIAL 303262 HAS A REGULAR BEVEL IN COMPARISON TO MATERIAL 304322 WHICH HAD A SHORT BEVEL. THIS MEANS THAT THE WAY THE NEEDLE PUNCTURES THE VIAL CHANGES. FOR MATERIAL 303262, THE ANGLE OF PENETRATION FOR THE VIAL SHOULD BE BETWEEN 45 TO 60 DEGREES. BASED ON THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT CORING RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. PHONE NUMBERS PROVIDED EXTEND BEYOND 10 DIGITS: PHONE- (B)(6). FAX-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLE CLOGGED AFTER ASPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: CANNULA(S) WAS "CLOGGED" XXX (ONCOL.) NOTICED SEVERAL TIMES THAT THE CANNULA WAS "CLOGGED". SHE WAS ABLE TO DRAW UP THE MEDICATION AND WANTED TO APPLY IT IN CARRIER SOLUTION, WHICH WAS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109498 BD CONVENTIONAL NEEDLE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 230716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown