BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT PERISAFE 18GA 3-1/2IN WEISS

    MDR report key: 8471536 · Received April 1, 2019

    Report

    Report Number
    2618282-2019-00155
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 25, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    CAZ
    UDI-DI
    00382904002732
    PMA / PMN Number
    K953790
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR REVIEW WAS COMPLETED ON (B)(6) 2019 ON THE IMPACTED LOT 8036527. DURING THE MANUFACTURING OF THE FINISH LOT 8036527, 2 BATCHES FROM THE CONNECTOR (PN 4882200AAU) WERE USED, 7094687 AND 7151718. EACH BATCH MATERIAL WAS INSPECTED AT INCOMING PER INSPECTION PROCEDURE SB856 ON (B)(6) 2017 FOR BATCH 7094687 AND ON (B)(6) 2017 FOR BATCH 7151718. USING THE ANSI Z1.4 LEVEL II NORMAL 0.25% AQL A VISUAL INSPECTION WAS PERFORMED; FOR BOTH BATCHES THE INSPECTION PASSED THE CRITERIA. THE MANUFACTURING PROCESS OF THE PERISAFE KIT LOT 8036527 WAS ON (B)(6) 2018, PACKED ON (B)(6) 2018 AND WAS RELEASED TO SHIPPING ON (B)(6) 2018. THE LOT QUANTITY WAS 6,260 EA. THE EXPIRATION DATE IS 28FEB23. NO NON-CONFORMANCE WAS GENERATED DURING THE MANUFACTURING PROCESS. NO SAMPLES WERE RECEIVED. THE DEFECT WAS NOT CONFIRMED SINCE NO PHOTOS NOR SAMPLES WERE RECEIVED. IN ADDITION, PER DHR REVIEW, THE INSPECTION RESULTS WHEN THE BATCHES 7094687 AND 7151718 WERE RECEIVED MET THE CRITERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A KIT PERISAFE 18GA 3-1/2IN WEISS WAS DAMAGE . THE FOLLOWING WAS REPORTED, "THE SUPPLY SERVICE HAS RECEIVED A COMPLAINT FROM THE POST ANESTHESIA UNIT REGARDING PERISAFE PLUS SET FOR EPIDURAL ANESTHESIA REF. (B)(4) DELIVERED BY YOUR COMPANY, SAYING THAT THE EPIDURAL CATHETER CONNECTOR TO THE FILTER IS DAMAGED , DOES NOT TIE UP, BEING NECESSARY TO OPEN A NEW KIT FOR USING THE CONNECTOR ONLY."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT A KIT PERISAFE 18GA 3-1/2IN WEISS WAS DAMAGE . THE FOLLOWING WAS REPORTED, "THE SUPPLY SERVICE HAS RECEIVED A COMPLAINT FROM THE POST ANESTHESIA UNIT REGARDING PERISAFE PLUS SET FOR EPIDURAL ANESTHESIA REF. (B)(4) DELIVERED BY YOUR COMPANY, SAYING THAT THE EPIDURAL CATHETER CONNECTOR TO THE FILTER IS DAMAGED , DOES NOT TIE UP, BEING NECESSARY TO OPEN A NEW KIT FOR USING THE CONNECTOR ONLY.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263239 KIT PERISAFE 18GA 3-1/2IN WEISS ANESTHESIA CONDUCTION KIT CAZ BD CARIBE LTD. 8036527 00382904002732

    Patients

    Seq Age Sex Outcome Treatment
    1 Other