BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD WHITACRE HIGH FLOW PENCIL POINT NEEDLE

    MDR report key: 4919539 · Received July 13, 2015

    Report

    Report Number
    2243072-2015-00129
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    June 9, 2015
    Report Date
    July 13, 2015
    Manufacturer
    BECTON DICKINSON
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A PHOTO OF THE USED DEVICE WAS INSPECTED AND RECEIVED A 27 GAUGE NEEDLE WITH ITS TIP MISSING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES FOR THE REPORTED LOT NUMBER 4162967. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, OUR QUALITY ENGINEER NOTES THAT THE NEEDLE SHOULD NOT BREAK IF IN CONTACT WITH SOFT TISSUE AND THAT THE BREAK WAS MOST LIKELY CAUSED BY CONTACT WITH BONE.

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. PHOTOS OF THE DEVICE WERE RETURNED AND WILL BE EVALUATED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD WHITACRE HIGH FLOW PENCIL POINT NEEDLE, THE TIP OF THE NEEDLE BROKE OFF WHILE IT WAS BEING REMOVED AND REMAINED IN THE SOFT TISSUE OF THE PATIENT'S KNEE. THE PATIENT RECEIVED X-RAYS. THE PATIENT DID NOT REQUIRE HOSPITALIZATION, MEDICATION, OR ANY FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PER X-RAYS RECEIVED ON (B)(6) 2015, THE INJECTION SITE WAS NOT IN THE PATIENT'S KNEE, RATHER IT WAS IN THE PATIENT'S LUMBAR SPINE AREA. PRIOR TO PERFORMING THE PROCEDURE (SPINAL ANESTHESIA), NO DEFECTS WERE DETECTED ON THE DEVICE AND WHILE PERFORMING THE PROCEDURE NO INCONVENIENCE WAS OBSERVED. THE DEVICE BROKE WHILE BEING REMOVED AND A SURGICAL EXPLORATION WAS DONE TO TRY AND REMOVE THE BROKEN NEEDLE. HOWEVER, THE NEEDLE COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453032 BD WHITACRE HIGH FLOW PENCIL POINT NEEDLE ANESTHESIA/SPINAL NEEDLE BSP BECTON DICKINSON 4162967

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention