BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8396220 · Received March 6, 2019

    Report

    Report Number
    9616656-2019-00212
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 25, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) BD PEN NEEDLE FROM LOT NUMBER 8004036 WITHOUT THE TEAR DROP LABEL ATTACHED (USED). CONSUMER REPORTED NEEDLE BREAK DURING INJECTION IN HER RIGHT THIGH. NOT SURE IF SHE GOT HER FULL DOSAGE. THE RETURNED PEN NEEDLE WAS EXAMINED AND EXHIBITED A BROKEN PATIENT END 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. DHRS ARE LEGALLY KEPT FOR 7 YEARS AFTER THE BATCH CREATION DATE BEFORE BEING REMOVED FROM ARCHIVE AND DESTROYED. LOT NUMBER 7092623 WAS MANUFACTURED ON 21JUN2007 (11 YEARS AFTER BATCH CREATION DATE), THUS THE DHR FOR THIS LOT NUMBER HAS BEEN DESTROYED. LOT NUMBER 8004036 WAS MANUFACTURED ON 05FEB2008 (11 YEARS AFTER BATCH CREATION DATE), THUS THE DHR FOR THIS LOT NUMBER HAS BEEN DESTROYED. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN PATIENT END CANNULA). 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 NEEDLES NEEDLE BROKE DURING INJECTION AND CUSTOMER NOT SURE IF SHE RECEIVED HER FULL DOSAGE. CONSUMER REPORTED NEEDLE BREAK DURING INJECTION IN HER RIGHT THIGH. NOT SURE IF SHE GOT HER FULL DOSAGE. STATED DID NOT GO FOR MEDICAL TREATMENT. DOES NOT PLAN ON GOING FOR MEDICAL TREATMENT. NO BLEEDING. STATED RE-USES SOMETIMES WHEN SHE'S SHORT PEN NEEDLES. ROTATES INJECTION SITES. HUB AVAILABLE TO SEND IN. STATED HER HUSBAND CHECKED HER INJECTION SITE TO SEE IF HE COULD FEEL THE NEEDLE. STATED HER HUSBAND WAS CHECKING THE FLOOR FOR THE NEEDLE JUST IN CASE IT FELL TO FLOOR.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES NEEDLE BROKE DURING INJECTION AND CUSTOMER NOT SURE IF SHE RECEIVED HER FULL DOSAGE. VERBATIM: CONSUMER REPORTED NEEDLE BREAK DURING INJECTION IN HER RIGHT THIGH. NOT SURE IF SHE GOT HER FULL DOSAGE. STATED DID NOT GO FOR MEDICAL TREATMENT. DOES NOT PLAN ON GOING FOR MEDICAL TREATMENT. NO BLEEDING. STATED RE-USES SOMETIMES WHEN SHE'S SHORT PEN NEEDLES. ROTATES INJECTION SITES. HUB AVAILABLE TO SEND IN. STATED HER HUSBAND CHECKED HER INJECTION SITE TO SEE IF HE COULD FEEL THE NEEDLE. STATED HER HUSBAND WAS CHECKING THE FLOOR FOR THE NEEDLE JUST IN CASE IT FELL TO FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186604 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 7092623 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Other