BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BARD-PARKER¿ HEIMLICH CHEST DRAIN VALVE

    MDR report key: 7793509 · Received August 17, 2018

    Report

    Report Number
    2618282-2018-00041
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    July 27, 2018
    Report Date
    September 10, 2018
    Manufacturer
    BD CARIBE LTD.
    Product Code
    KDQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THREE SAMPLES FOR LOT 7165656 AND ONE SAMPLE FROM LOT 6252851 WERE PHYSICALLY RECEIVED IN BD JUNCOS FOR EVALUATION. BD JUNCOS WAS ABLE TO CONFIRM CUSTOMER INDICATED DEFECT WITH SAMPLES RECEIVE AS EVIDENCE. DEVICE HISTORY RECORD REVIEW FOR THE LOT NUMBERS 6252851 & 7165656 WERE PERFORMED AND NO DISCREPANCIES OR DEVIATIONS WERE OBSERVED. ALL THE INSPECTIONS PERFORMED AS ESTABLISHED PER PROCEDURES WITH SATISFACTORY RESULTS. INVESTIGATION CONCLUSION: THE MOST PROBABLE CAUSE OF THIS NON-CONFORMANCE IS RELATED TO RAW MATERIAL POSSIBLE HAVING BLACK SPOTS CONDITION. CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: B.2. EVENT ATTRIBUTED TO: OTHER D.8. DEVICE SINGLE USE?: NO H.3. DEVICE RETURNED TO MANUFACTURER: YES H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THAT THE BD BARD-PARKER¿ HEIMLICH CHEST DRAIN VALVE HAD BLACK SPOTS ON THE PRODUCT FOREIGN MATTER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6252851, EXPIRATION DATE: 2021-09-30, MANUFACTURE DATE: 2016-09-08. MEDICAL DEVICE LOT #: 7165656, EXPIRATION DATE: 2022-06-30, MANUFACTURE DATE: 2017-06-14. 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 BEFORE USE THAT THE BD BARD-PARKER¿ HEIMLICH CHEST DRAIN VALVE HAD BLACK SPOTS ON THE PRODUCT FOREIGN MATTER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636516 BD BARD-PARKER¿ HEIMLICH CHEST DRAIN VALVE VALVE HEIMLICH BNS KDQ BD CARIBE LTD. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other