BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ ULTRA-FINE PEN NEEDLES

    MDR report key: 8275799 · Received January 24, 2019

    Report

    Report Number
    9616656-2019-00005
    Event Type
    Injury
    Date Received
    January 24, 2019
    Date of Event
    January 1, 2019
    Report Date
    January 29, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00885403801518
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS ARE AS FOLLOWS: PMA / 510(K)#: K162516.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT USED A BD¿ ULTRA-FINE PEN NEEDLES AND THE NEEDLE BROKE OFF ON THE LEFT SIDE OF HER ABDOMEN. "RECEIVED MEDICAL ATTENTION WITH AN X-RAY AND ULTRASOUND. UNABLE TO LOCATE THE NEEDLE THAT BROKE OFF. STATED THE DOCTOR NUMBED THE AFFECTED AREA WITH LIDOCAINE AND CUT/PROBED AREA TRYING TO LOCATE THE NEEDLE. WAS GIVEN TWO ANTIBIOTICS: SHE TAKES ONE, 4 TIMES PER DAY AND A SECOND, TWO TIMES PER DAY. STATED SHE WAS TOLD TO FOLLOW UP WITH HER PRIMARY PHYSICIAN."

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT USED A BD¿ ULTRA-FINE PEN NEEDLES AND THE NEEDLE BROKE OFF ON THE LEFT SIDE OF HER ABDOMEN. "RECEIVED MEDICAL ATTENTION WITH AN X-RAY AND ULTRASOUND. UNABLE TO LOCATE THE NEEDLE THAT BROKE OFF. STATED THE DOCTOR NUMBED THE AFFECTED AREA WITH LIDOCAINE AND CUT/PROBED AREA TRYING TO LOCATE THE NEEDLE. WAS GIVEN TWO ANTIBIOTICS: SHE TAKES ONE, 4 TIMES PER DAY AND A SECOND, TWO TIMES PER DAY. STATED SHE WAS TOLD TO FOLLOW UP WITH HER PRIMARY PHYSICIAN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68301 BD¿ ULTRA-FINE PEN NEEDLES AUTOINJECTOR NEEDLE FMI BECTON DICKINSON AND CO. 7262583 00885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention