BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 6672525 · Received June 28, 2017

    Report

    Report Number
    9616656-2017-00048
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    June 2, 2017
    Report Date
    October 4, 2017
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: THE COMPLAINT INFORMATION WAS INITIALLY PROVIDED BY A PHARMACIST FROM (B)(6). THE PHARMACIST ALSO PROVIDED CONTACT INFORMATION FOR THE CONSUMER AND ADDITIONAL INFORMATION WAS OBTAINED. THE INFORMATION FOR THE PHARMACIST IS AS FOLLOWS: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED ( 10 ) 4MM, 32G BD PEN NEEDLES, UNOPENED (NOT USED). CUSTOMER STATES A NEEDLE BROKE OFF AT HIS SON LEG. ALL OF THE RETURNED UNOPENED PEN NEEDLES WERE EXAMINED FOR BROKEN NEEDLE AT NP END OF CANNULA. NONE OF THE 10 NEEDLES EXAMINED WERE BROKEN AT THE NP END OF THE CANNULA, NOR ON THE NPE OF THE CANNULA EITHER. ALL TEN (10) RETURNED NEEDLES WERE THEN TESTED FOR POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 32G: 0.0090¿- 0.0095¿): DATA: POINT (PE/NPE), OUTER DIAMETER (IN), LUBE: SAMPLE 1: GOOD/GOOD, 0.0090, GOOD; SAMPLE 2: GOOD/GOOD, 0.0091, GOOD; SAMPLE 3: GOOD/GOOD, 0.0091, GOOD; SAMPLE 4: GOOD/GOOD, 0.0090, GOOD; SAMPLE 6: GOOD/GOOD, 0.0092, GOOD; SAMPLE 7: GOOD/GOOD, 0.0091, GOOD; SAMPLE 8: GOOD/GOOD, 0.0090, GOOD; SAMPLE 9: GOOD/GOOD, 0.0091, GOOD; SAMPLE 10: GOOD/GOOD, 0.0092, GOOD. 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. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. THE SAMPLES RETURNED DID NOT EXHIBIT THE ALLEGED DEFECT.

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6293782. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE BROKE OFF IN A CHILD PATIENT'S LEG DURING INJECTION. THE PATIENT WAS TAKEN TO A DOCTOR'S OFFICE AND RECEIVED X-RAYS. THE PATIENT WAS ALSO SCHEDULED TO HAVE SURGERY TO REMOVE THE BROKEN NEEDLE. THE PATIENT'S PARENT ALSO REPORTED THAT THE PATIENT RECEIVED THREE INJECTIONS PER DAY, THAT THE NEEDLE WAS NOT REUSED, AND THAT THERE WAS NO BLEEDING BUT THERE IS MINOR DISCOMFORT WHEN THE INJECTION AREA IS TOUCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455559 32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON, DICKINSON AND CO. 6293782

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention