BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11088214 · Received December 29, 2020

    Report

    Report Number
    2243072-2020-02175
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    November 10, 2020
    Report Date
    July 12, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    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

    H.6. INVESTIGATION: BATCH RECORD LOT NO. 9021609 IS IN PRODUCTION IN LATE MARCH 2019 AND LOT NO. 9072974 IS IN PRODUCTION IN LATE APRIL 2019. WE SCRUTINIZED THE MANUFACTURING RECORDS, ETC., BUT FOUND NO ABNORMALITIES. SORTING RECORD LOT NO. 9021609 IS 100% SORTED BY CAMERA INSPECTION MACHINE AND VISUAL INSPECTION (STRICT INSPECTION) FROM LATE JULY TO EARLY AUGUST 2019 AT THE FUKUSHIMA PLANT. IN ADDITION, LOT NO. 9072974 CARRIES OUT THE SAME 100% SELECTION AS ABOVE FROM THE BEGINNING TO THE END OF AUGUST 2019. WE SCRUTINIZED THE INSPECTION RECORDS, ETC., BUT FOUND NO ABNORMALITIES. RETURN SAMPLE WHEN WE CHECKED 7 ACTUAL PRODUCTS, THE NEEDLE TUBE OF THE 2 ACTUAL PRODUCTS WAS SLIGHTLY TILTED, BUT NO DEFORMATION WAS OBSERVED AT THE NEEDLE TIP. THE INCLINATION IS LESS THAN 2.5 DEGREES, AND IT IS CONSIDERED AS A GOOD PRODUCT ACCORDING TO THE STANDARD. IN ONE ACTUAL PRODUCT, THE NEEDLE HUB WAS DAMAGED AND THE NEEDLE TUBE WAS SLIGHTLY TILTED. MOST OF THE NEEDLE HUBS OF THE OTHER 4 NEEDLES WERE MISSING, BUT NO DEFORMATION OF THE NEEDLE TUBE WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PIR3-255 HYPOINT NDL 27GA1/2IN SORTED IR NEEDLE WAS DIFFICULT TO CONNECT AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PHYSICIAN FOUND THAT A NEEDLES WAS BENT BEFORE USE. THE NEEDLES WERE REPLACED, BUT THREE OF THEM COULD NOT BE USED FOR INJECTION BECAUSE THEY COULD NOT BE ATTACHED CORRECTLY OR LIQUID LEAKAGE OCCURRED. NO HEALTH HAZARD TO VACCINATED PEOPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4). INVESTIGATION SUMMARY: REPORTED CONDITION DOES NOT MEET SPECIFICATION. LOT NO. 9021609 IS IN PRODUCTION IN LATE MARCH 2019 AND LOT NO. 9072974 IS IN PRODUCTION IN LATE APRIL 2019. WE SCRUTINIZED THE MANUFACTURING RECORDS, ETC., BUT FOUND NO ABNORMALITIES. LOT NO. 9021609 IS 100% SORTED BY CAMERA INSPECTION MACHINE AND VISUAL INSPECTION (STRICT INSPECTION) FROM LATE JULY TO EARLY AUGUST 2019 AT THE (B)(6) PLANT. IN ADDITION, LOT NO. 9072974 CARRIES OUT THE SAME 100% SELECTION AS ABOVE FROM THE BEGINNING TO THE END OF AUGUST 2019. WE SCRUTINIZED THE INSPECTION RECORDS, ETC., BUT FOUND NO ABNORMALITIES. WHEN WE CHECKED 7 ACTUAL PRODUCTS, THE NEEDLE TUBE OF THE 2 ACTUAL PRODUCTS WAS SLIGHTLY TILTED, BUT NO DEFORMATION WAS OBSERVED AT THE NEEDLE TIP. THE INCLINATION IS LESS THAN 2.5 DEGREES, AND IT IS CONSIDERED AS A GOOD PRODUCT ACCORDING TO THE STANDARD. IN ONE ACTUAL PRODUCT, THE NEEDLE HUB WAS DAMAGED AND THE NEEDLE TUBE WAS SLIGHTLY TILTED. MOST OF THE NEEDLE HUBS OF THE OTHER 4 NEEDLES WERE MISSING, BUT NO DEFORMATION OF THE NEEDLE TUBE WAS OBSERVED. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PIR3-255 HYPOINT NDL 27GA1/2IN SORTED IR NEEDLE WAS DIFFICULT TO CONNECT AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PHYSICIAN FOUND THAT A NEEDLES WAS BENT BEFORE USE. THE NEEDLES WERE REPLACED, BUT THREE OF THEM COULD NOT BE USED FOR INJECTION BECAUSE THEY COULD NOT BE ATTACHED CORRECTLY OR LIQUID LEAKAGE OCCURRED. NO HEALTH HAZARD TO VACCINATED PEOPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555073 PIR3-255 HYPOINT NDL 27GA1/2IN SORTED IR SYRINGE FMF BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1