BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8587334 · Received May 7, 2019

    Report

    Report Number
    9616656-2019-00426
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 20, 2019
    Report Date
    May 17, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403801518
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) 31G X 8MM BD PEN NEEDLE WITHOUT THE TEAR DROP LABEL ATTACHED (USED). CONSUMER REPORTED NEEDLE BROKE OFF IN SKIN. THE RETURNED SAMPLE WAS EXAMINED AND EXHIBITED A BROKEN PATIENT-END CANNULA. NO EVIDENCE OF MANUFACTURING DEFECTS WERE OBSERVED ON EITHER THE NEEDLE OR HUB. THE LIKELY CAUSE OF THE PATIENT END CANNULA BREAK IS HUMAN FACTOR. 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. THE POSSIBLE ROOT CAUSE FOR THIS ISSUE IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLE BROKE OFF INTO THE INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320109 BATCH NO. 6110621 IT WAS REPORTED THAT NEEDLE BROKE OFF INTO INJECTION SITE IN CAT. MEDICAL ATTENTION WITH X-RAY AND SURGERY TO REMOVE NEEDLE FROM CAT. VERBATIM: PET OWNER REPORTED NEEDLE BROKE OFF IN SKIN, (CAT) OCCURRED ON 04/20/2019. STATED TOOK CAT TO VCA ARBORETUM VIEW ANIMAL HOSPITAL. STATED THEY TOOK X-RAY CONFIRMED BREAK JUST BELOW HIS NECK. STATED SURGERY WAS PERFORMED THAT DAY TO REMOVE NEEDLE. STATED NO INFECTION REPORTED AND NO FOLLOW UP NECESSARY. PET OWNER HAS THE NEEDLE THAT WAS RETRIEVED FROM CAT AND HAS SYRINGE THAT IT BROKE OFF OF TO SEND IN. STATED OUT OF POCKET OF EXPENSES. 226.85. STATED HAS RECEIPT. STATED DOCTOR WAS ABLE EXTRACT NEEDLE EASILY AND THERE WAS NO CUTTING INVOLVED. LOT: 6110621, 31G, 8MM, ITEM: 320109.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLE BROKE OFF INTO THE INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320109, BATCH NO. 6110621. IT WAS REPORTED THAT NEEDLE BROKE OFF INTO INJECTION SITE IN CAT. MEDICAL ATTENTION WITH X-RAY AND SURGERY TO REMOVE NEEDLE FROM CAT. VERBATIM: PET OWNER REPORTED NEEDLE BROKE OFF IN SKIN, (CAT) OCCURRED ON (B)(6) 2019. STATED TOOK CAT TO VCA ARBORETUM VIEW ANIMAL HOSPITAL. STATED THEY TOOK X-RAY CONFIRMED BREAK JUST BELOW HIS NECK. STATED SURGERY WAS PERFORMED THAT DAY TO REMOVE NEEDLE. STATED NO INFECTION REPORTED AND NO FOLLOW UP NECESSARY. PET OWNER HAS THE NEEDLE THAT WAS RETRIEVED FROM CAT AND HAS SYRINGE THAT IT BROKE OFF OF TO SEND IN. STATED OUT OF POCKET OF EXPENSES. (B)(6). STATED HAS RECEIPT. STATED DOCTOR WAS ABLE EXTRACT NEEDLE EASILY AND THERE WAS NO CUTTING INVOLVED. LOT: 6110621, 31G, 8MM, ITEM: 320109.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382002 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 6110621 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention