BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEN NEEDLE

    MDR report key: 3009222 · Received March 14, 2013

    Report

    Report Number
    9616656-2013-00010
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISSUE: NEEDLE BREAKOFF. EVAL SUMMARY: CUSTOMER RETURNED (92) 5MM, 31G PEN NEEDLES (2 OPEN, 90 SEALED) FROM LOT # 2066610. CUSTOMER STATES THAT AFTER PULLING THE PEN NEEDLE OUT OF HER STOMACH, SHE NOTICED THE NEEDLE WAS NOT THERE. A 30 OUT OF 90 SEALED PEN NEEDLES WERE EXAMINED AND NO BENT, BROKEN, OR DETACHED IV OR NP END OF THE CANNULA WAS OBSERVED. BOTH OPEN SAMPLES WERE RETURNED W/O INNER SHIELD. THE TWO PEN NEEDLES WERE EXAMINED AND ONE EXHIBITED A BROKEN IV END OF THE CANNULA. MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE BROKEN HUB END, CRACKED ADHESIVE, AND TUBING OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). WHEN VIEWED TOGETHER, THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. FURTHERMORE, THE PRESENCE OF THE DEEP INDENTATION DISPLAYED IN THE ADHESIVE AND PLASTIC HUB AREA, CREATED BY THE CANNULA SHAFT FURTHER ATTESTS TO THE SEVERE BENDING THAT POSSIBLY OCCURRED DURING MFG PROCESS. REMOVAL OF SOME OF THE ADHESIVE MADE THIS OBSERVATION MORE APPARENT. ALSO, THIS SAMPLE AND 6 OUT OF 30 SEALED SAMPLES EXHIBITED ADHESIVE RUNOFF ONTO THE HUB. THE NEEDLE BREAK OFF AND ADHESIVE RUNOFF ISSUE WILL BE CONFIRMED AS DEFECTS. PRODUCT WILL BE FORWARDED TO MFG FOR FURTHER INVESTIGATION. COMPLAINT HISTORY CHECK WAS PERFORMED AND AS OF ((B)(4) 2013) THIS IS THE 1ST COMPLAINT AGAINST LOT NUMBER 2066610 FOR SIMILAR ISSUES. INFO WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY.

    Description of Event or Problem · 1

    HOLD SBF. CONSUMER REPORTED AFTER PULLING PEN NEEDLE OUT OF HER STOMACH, NOTICED NEEDLE WAS NOT THERE. CONSUMER WENT TO ER AND HAD X-RAYS DONE. PT HAD A TETANUS SHOT AND WAS ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108214 BD PEN NEEDLE PEN NEEDLE, HYPODERMIC FMI BD 2066610

    Patients

    Seq Age Sex Outcome Treatment
    1