BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE

    MDR report key: 5007824 · Received August 13, 2015

    Report

    Report Number
    9616656-2015-00003
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    August 4, 2015
    Report Date
    May 9, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WEILL BE FILED.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON (B)(6) 2017, (B)(6) WITH FDA MEDWATCH REQUESTED THAT THIS REPORT BE RESUBMITTED WITHOUT THE LEADING ZEROES ON THE MANUFACTURER'S REPORT NUMBER. THIS SUBMISSION IS FOR COMPLIANCE WITH THAT REQUEST. RESULTS - 64 UNUSED AND SEALED REPRESENTATIVE SAMPLES WERE RECEIVED FOR EVALUATION. THERE WERE 15 SEALED SAMPLES FROM LOT NO. 4086177, 11 SEALED SAMPLES FROM LOT. NO., 4268324, 17 SEALED SAMPLES FROM LOT NO. 4247041, 16 SEALED SAMPLES FROM LOT. NO. 4142283, 1 SEALED SAMPLE FROM LOT. NO. 3073380, 2 SEALED SAMPLES FROM LOT. NO. 3184254. NO SAMPLES FROM THE REPORTED LOT NUMBER 4310382 WERE RETURNED. A MICROSCOPIC ANALYSIS OF 30 OF THE REPRESENTATIVE SAMPLES REVEALED NO PROBLEMS OR ABNORMALITIES WITH ANY OF THE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER 4310382 AND FOR THE LOT NUMBERS OF THE REPRESENTATIVE SAMPLES REVEALED NO IRREGULARITIES DURING THE MANUFACTURING PROCESS. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS THE RETURNED SAMPLES MET MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TWO INCIDENTS OF A NEEDLE BREAKING OFF IN USE WHILE USING A BD MICRO-FINE ULTRA INSULIN PEN NEEDLE. FOR THE FIRST INCIDENT, THE PATIENT USED THE SAME NEEDLE TWICE AND IT BROKE OFF IN THE PATIENT'S ABDOMEN. THE PATIENT RECEIVED AN X-RAY AND HAD SURGERY TO TRY AND REMOVE THE BROKEN NEEDLE, BUT THE NEEDLE COULD NOT BE FOUND. FOR THE SECOND INCIDENT, THE PATIENT HAD A NEEDLE BREAK OFF IN HIS/HER ABDOMEN, BUT HE/SHE WAS ABLE TO REMOVE IT WITH TWEEZERS AND NO MEDICAL INTERVENTION WAS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TWO INCIDENTS OF A NEEDLE BREAKING OFF IN USE WHILE USING A BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE. FOR THE FIRST INCIDENT, THE PATIENT USED THE SAME NEEDLE TWICE AND IT BROKE OFF IN THE PATIENT'S ABDOMEN. THE PATIENT RECEIVED AN X-RAY AND HAD SURGERY TO TRY AND REMOVE THE BROKEN NEEDLE, BUT THE NEEDLE COULD NOT BE FOUND. FOR THE SECOND INCIDENT, THE PATIENT HAD A NEEDLE BREAK OFF IN HIS/HER ABDOMEN BUT HE/SHE WAS ABLE TO REMOVE IT WITH TWEEZERS AND NO MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532307 BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE INSULIN PEN NEEDED FMI BECTON DICKINSON AND CO. 4310382

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention