BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH NEEDLE

    MDR report key: 10431601 · Received August 20, 2020

    Report

    Report Number
    3002682307-2020-00257
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/24/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1903305 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE SAMPLES AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, BLACK TAPE WAS OBSERVED IN THE PACKAGING FILM. THIS BLACK TAPE IS USED TO INDICATE WHEN THE FILM REEL SHOULD BE REMOVED DURING THE PACKAGING PROCESS. A VISION SYSTEM IS IN PLACE TO DETECT THIS BLACK TAPE AND HALT THE PACKAGING PROCESS. THE SYSTEM DID NOT WORK AS EXPECTED AND THE BLACK TAPE WAS NOT REMOVED DURING PACKAGING, RESULTING IN THIS REPORTED INCIDENT. IN RESPONSE TO THIS INCIDENT, THE DETECTION SYSTEM HAS BEEN CHECKED AND ALL APPLICABLE PERSONNEL HAVE BEEN MADE AWARE OF THIS POTENTIAL ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 BD¿ 20 ML SYRINGE WITH NEEDLES EXPERIENCED DAMAGED OR OPEN UNIT PACKAGES/SEALS WHERE STERILITY WAS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING A 20ML SYRINGE IN CLINIC, IT WAS FOUND THAT ABNORMAL BLACK PLASTIC APPEARED AT THE NORMAL TEAR, AND IT WAS NOT SEALED, WHICH CAUSED THE SYRINGE TO BE COMPLETELY EXPOSED TO THE AIR.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 8 BD¿ 20 ML SYRINGE WITH NEEDLES EXPERIENCED DAMAGED OR OPEN UNIT PACKAGES/SEALS WHERE STERILITY WAS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING A 20 ML SYRINGE IN CLINIC, IT WAS FOUND THAT ABNORMAL BLACK PLASTIC APPEARED AT THE NORMAL TEAR, AND IT WAS NOT SEALED, WHICH CAUSED THE SYRINGE TO BE COMPLETELY EXPOSED TO THE AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899541 BD 20 ML SYRINGE WITH NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1903305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other