BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 6850017 · Received September 7, 2017

    Report

    Report Number
    1213809-2017-00102
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 15, 2017
    Report Date
    December 4, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A TOTAL OF 54 SEALED PACKAGED SAFETY GLIDE NEEDLES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #6001842 (P/N 305916) (1INCH NEEDLE CANNULA). ALL NEEDLES HAD THE 1 INCH NEEDLE SHIELD. THE SAMPLES WERE OPENED TO EVALUATE THE NEEDLE CANNULA LENGTH. TWO NEEDLES HAD 1 INCH CANNULA WHILE 52 NEEDLES HAD 5/8 INCH CANNULA. CONCLUSION: BASED ON SAMPLES, THE INVESTIGATION CONCLUDED: CONFIRMED, AS BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE UNDER CRS #(B)(4), SITUATIONAL ANALYSIS (B)(4) AND CAPA #(B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGE OF A 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE STATED 25G 1 INCH. HOWEVER, HALF WERE REPORTED SHORTER IN LENGTH. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630431 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC SYRINGE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other