BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11180543 · Received January 15, 2021

    Report

    Report Number
    2243072-2021-00118
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 1, 2020
    Report Date
    January 13, 2021
    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 · 1

    OEM MANUFACTURER: (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9072974, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-08-02, MEDICAL DEVICE LOT #: 9187116, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-08-09. (B)(4). INVESTIGATION SUMMARY: RETURN SAMPLE. WHEN THE HIGH POINT NEEDLE OF THE ACTUAL PRODUCT WAS REMOVED FROM THE SYRINGE AND THE INSIDE OF THE NEEDLE TUBE WAS VISUALLY OBSERVED AND OBSERVED WITH A MICROSCOPE, NO CLOGGING OF THE NEEDLE TUBE WAS OBSERVED. WHEN I REATTACHED THE HIGH POINT NEEDLE TO THE SYRINGE AND SUCKED WATER FROM THE NEEDLE TIP, I WAS ABLE TO SUCK IT WITHOUT ANY PROBLEM. WHEN I PUSHED THE PLUNGER ROD, WATER WAS DISCHARGED FROM THE NEEDLE TIP WITHOUT ANY PROBLEM. I REPEATED SUCTION AND DISCHARGE SEVERAL TIMES, BUT NO ABNORMALITY WAS FOUND. HE ALSO FOUND A DEFORMATION OF LESS THAN 0.2 MM ON THE NEEDLE TIP. BATCH RECORD: LOT NO. 9072974 IS IN PRODUCTION IN LATE APRIL 2019 AND LOT NO. 9187116 IS IN PRODUCTION IN MID-JULY 2019. WE SCRUTINIZED THE MANUFACTURING RECORDS, ETC., BUT FOUND NO ABNORMALITIES. SORTING RECORD: LOT NO. 9072974 IS 100% SORTED BY CAMERA INSPECTION MACHINE AND VISUAL INSPECTION (STRICT INSPECTION) FROM THE BEGINNING TO THE END OF AUGUST 2019 AT THE FUKUSHIMA PLANT. IN ADDITION, LOT NO. 9187116 CARRIES OUT THE SAME 100% SELECTION AS ABOVE FROM MID-AUGUST TO EARLY SEPTEMBER 2019. WE SCRUTINIZED THE INSPECTION RECORDS, ETC., BUT FOUND NO ABNORMALITIES. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE WITH THE SAMPLE PROVIDED. ROOT CAUSE DESCRIPTION: ROOT COUSE. NO CLOGGING WAS FOUND IN THE NEEDLE TUBE OF THE ACTUAL PRODUCT, AND THE CAUSE OF THE EVENT "LIQUID DID NOT COME OUT" COULD NOT BE ESTIMATED. A SMALL DEFORMATION WAS FOUND IN THE NEEDLE TIP OF THE ACTUAL PRODUCT, BUT IT SEEMS THAT IT HAS NOTHING TO DO WITH THIS EVENT. REGARDING THE DEFORMATION OF THE NEEDLE TIP, IT WAS NOT POSSIBLE TO IDENTIFY AT WHAT POINT IN TIME THIS SURVEY OCCURRED. RATIONALE: 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 FLUID WAS BLOCKED FROM COMING OUT OF THE PIR3-255 HYPOINT NDL 27GA1/2IN SORTED IR. THIS OCCURRED 1 TIME IN LOT 9072974, AND AN UNSPECIFIED NUMBER OF TIMES IN LOT 9187116. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FLUID WAS UNABLE TO COME OUT OF THE NEEDLE. THE TIP OF NEEDLE WAS SLIGHTLY DEFORMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74111 PIR3-255 HYPOINT NDL 27GA1/2IN SORTED IR HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1