BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPOINT NDL27GA1/2IN

    MDR report key: 11205971 · Received January 20, 2021

    Report

    Report Number
    8041187-2021-00044
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 8, 2020
    Report Date
    February 12, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903002559
    PMA / PMN Number
    K070440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON DHR REVIEW, THERE IS NO ABNORMALITY THAT MAY INFLUENCED THIS NON-CONFORMANCE. THERE ARE NO RETURNED SAMPLES FOR INVESTIGATION. BASED ON THE RETURNED PHOTOS, PIERCED SHIELD WAS OBSERVED. AFTER SHIELD LOADING STATION, THE SHIELD HEIGHT SENSOR WILL REJECT PART WITH SLANTED SHIELD WHICH MAY CAUSE PIERCED SHIELD AT SHIELD PRESS STATION. THE PROBABLE CAUSE MAYBE DUE TO PRODUCTION ASSOCIATED OVERLOOKED TO CLEAR THE PARTS WHEN THERE IS ERROR TRIGGERED AT SHIELD HEIGHT SENSOR. ACTIONS WERE IMPLEMENTED TO REVISE OJT-21298 TO ADD IN NEW TASK ELEMENT TO CLEAR THE AN WITH SLANTED SHIELD OBSERVED ON TASK "RECOVERY ACTION FOR THE ERROR CODE #19-2". PRODUCTION BATCH IS PRODUCED IN AUG 2019 WHICH HAPPENED PRIOR THE ACTION IMPLEMENTATION DATE IS ON OCT 2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HYPOINT NDL27GA1/2IN HAD THE NEEDLE POINT PENETRATE THOUGH THE SHIELD BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "NEEDLE PIERCED THROUGH NEEDLE CONTAINER. ON (B)(6) 2020, A QA RESPONSIBLE PERSON WAS INFORMED BY TERRITORY MANAGER REGARDING A PRODUCT COMPLAINT ON RECORMON 5000 IU BATCH NO. H0704H01. THE COMPLAINT CAME FROM THE NAKORNPING HOSPITAL, CHIANG MAI, THAILAND. A BENT NEEDLE PIERCING A NEEDLE CONTAINER WAS FOUND CO-PACKED IN THE ROCHE DRUG PRODUCT. THE CO-PACKED NEEDLE WAS NOT OPENED AND WAS KEPT IN THE ORIGINAL PACKAGE (SEE PICTURES BELOW). THE LOT NUMBER OF DEFECTIVE NEEDLE IS LOT 9155564, EXP 2024-06-30. AFTER CONFIRMING WITH COMPLAINANT, THE RESPECTIVE BATCH OF RECORMON 5000 IU WAS ADMINISTERED TO THE PATIENT USING ANOTHER NEW NEEDLE, THE DEFECTIVE NEEDLE WAS NOT USED. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN AND THE COMPLAINANT REQUESTS THE INVESTIGATION OUTCOME. AS ADDITIONAL INFORMATION, THE IMPACTED BATCH WAS ALREADY REPORTED IN ¿A BENT NEEDLE¿ COMPLAINT IN (B)(6) 2020, BUT THE NEEDLE CONTAINER WAS NOT PIERCING THE NEEDLE CONTAINER.".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HYPOINT NDL27GA1/2IN HAD THE NEEDLE POINT PENETRATE THOUGH THE SHIELD BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "NEEDLE PIERCED THROUGH NEEDLE CONTAINER. ON 08 DEC 2020, A QA RESPONSIBLE PERSON WAS INFORMED BY TERRITORY MANAGER REGARDING A PRODUCT COMPLAINT ON RECORMON 5000 IU BATCH NO. H0704H01. THE COMPLAINT CAME FROM THE (B)(6) HOSPITAL (B)(6). A BENT NEEDLE PIERCING A NEEDLE CONTAINER WAS FOUND CO-PACKED IN THE ROCHE DRUG PRODUCT. THE CO-PACKED NEEDLE WAS NOT OPENED AND WAS KEPT IN THE ORIGINAL PACKAGE . THE LOT NUMBER OF DEFECTIVE NEEDLE IS LOT 9155564, EXP 2024-06-30. AFTER CONFIRMING WITH COMPLAINANT, THE RESPECTIVE BATCH OF RECORMON 5000 IU WAS ADMINISTERED TO THE PATIENT USING ANOTHER NEW NEEDLE, THE DEFECTIVE NEEDLE WAS NOT USED. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR RETURN AND THE COMPLAINANT REQUESTS THE INVESTIGATION OUTCOME. AS ADDITIONAL INFORMATION, THE IMPACTED BATCH WAS ALREADY REPORTED IN A BENT NEEDLE COMPLAINT IN NOVEMBER 2020, BUT THE NEEDLE CONTAINER WAS NOT PIERCING THE NEEDLE CONTAINER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102069 HYPOINT NDL27GA1/2IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 300255 9155564 00382903002559

    Patients

    Seq Age Sex Outcome Treatment
    1