BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIR3-255 HYPOINT NDL 27GA1/2IN SORTED IR

    MDR report key: 10814246 · Received November 9, 2020

    Report

    Report Number
    2243072-2020-01799
    Event Type
    Malfunction
    Date Received
    November 9, 2020
    Date of Event
    October 6, 2020
    Report Date
    November 17, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020. H.6. INVESTIGATION: BASED ON THE RETURNED SAMPLE ANALYSIS, A BLACK EMBEDDED FOREIGN MATTER WAS OBSERVED INSIDE THE NEEDLE HUB. THE NEEDLE HUB IS AN MOLDED PRODUCT. THERE IS NO ISSUE IN THE MANUFACTURING RECORDS OF LOT NO. 902160. LOT NO. 9021609 IS 100% INSPECTED BY CAMERA AND VISUAL INSPECTION. IN ADDITION, LOT NO. 9072974 WAS CONDUCTING THE SAME 100% INSPECTION. THE INSPECTION RECORDS FOR BOTH LOTS WERE REVIEWED, BUT THERE WAS NO ISSUE IN THE RECORDS. AS THE EMBEDDED FOREIGN MATTER OBSERVED IS VERY SMALL, IT MAY BE DIFFICULT TO VISUALLY DETECT THE FOREIGN MATTER FROM OUTSIDE OF THE NEEDLE SHIELD. THE BLACK EMBEDDED FOREIGN MATTER OBSERVED IS DETERMINED A MATERIAL LIKE POLYPROPYLENE RESIN THAT HAS BEEN THERMALLY DETERIORATED AND CARBONIZED AND EMBEDDED INTO THE NEEDLE HUB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PIR3-255 HYPOINT NDL 27GA1/2IN SORTED IR HAD FOREIGN MATTER BETWEEN THE NEEDLE AND THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A NURSE FOUND BLACK DEBRIS ON THE JUNCTION BETWEEN THE BODY OF THE SYRINGE AND THE NEEDLE WHILE PREPARING FOR INOCULATION.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9021609, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-07-29. MEDICAL DEVICE LOT #: 9072974, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-08-02. 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 PIR3-255 HYPOINT NDL 27GA1/2IN SORTED IR HAD FOREIGN MATTER BETWEEN THE NEEDLE AND THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A NURSE FOUND BLACK DEBRIS ON THE JUNCTION BETWEEN THE BODY OF THE SYRINGE AND THE NEEDLE WHILE PREPARING FOR INOCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272065 PIR3-255 HYPOINT NDL 27GA1/2IN SORTED IR NEEDLE FMI BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1