BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30GA 1/2IN

    MDR report key: 11115071 · Received January 5, 2021

    Report

    Report Number
    3002682307-2020-00441
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 7, 2020
    Report Date
    March 18, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 200207. D4: MEDICAL DEVICE EXPIRATION DATE: 01/31/2025. H4: DEVICE MANUFACTURE DATE: 2/4/2020. D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/4/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR POTENTIAL BATCH NUMBER 200207, WHICH WAS OBTAINED THROUGH THE RETURNED SAMPLES. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS INCIDENT, THE AFFECTED SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, SAMPLES WITHIN BLISTER PACKAGES CORRESPONDING TO MATERIAL 302200 AND BATCH 200118 WERE RETURNED ALONGSIDE A FOLDED SHELF CARTON REFERENCING MATERIAL 304000 AND BATCH 200207. AFTER A THOROUGH INVESTIGATION AT THE MANUFACTURING FACILITY, IT HAS BEEN DETERMINED THAT THERE IS NO EVIDENCE TO INDICATE THE MIX UP OF PRODUCT OCCURRED WITHIN THE MANUFACTURING PLANT. BATCH 200207 WAS PRODUCED WITHIN MACHINE 2101 BETWEEN FEBRUARY 4TH AND FEBRUARY 12TH. BATCH 200118 WAS PRODUCED WITHIN MACHINE 2103 BETWEEN JANUARY 22ND AND JANUARY 24TH. NO REWORK WAS PERFORMED FOR THIS BATCH. THE SHELF CARTONS ARE PACKAGED AUTOMATICALLY WITH A DETECTION SYSTEM IN PLACE TO IDENTIFY ANY POSSIBLE DEFECTS. BASED ON THE INVESTIGATION RESULTS, A MANUFACTURING RELATED DEFECT COULD NOT BE DETERMINED FOR THIS INCIDENT. IT IS POSSIBLE THAT THIS ISSUE RESULTED FROM A PRODUCT MIX-UP OUTSIDE OF THE MANUFACTURING PLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 NEEDLE 30GA 1/2IN EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SUBJECT: BD MICROLANCE 3 30G * 1/2 0.3 * 19MM EXPIRY 01/25 WE REQUEST A NEW PACK AS WELL AS TO COMMENT ON THE FACT THAT THE CONTENT HAS THE SIZE 27 G 0.4 * 19MM NUMBER 20.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 20 NEEDLE 30GA 1/2IN EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SUBJECT: BD MICROLANCE 3 30G * 1/2 0.3 * 19MM EXPIRY 01/25 WE REQUEST A NEW PACK AS WELL AS TO COMMENT ON THE FACT THAT THE CONTENT HAS THE SIZE 27 G 0.4 * 19MM NUMBER 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17716 NEEDLE 30GA 1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 200207

    Patients

    Seq Age Sex Outcome Treatment
    1