BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE NEEDLE

    MDR report key: 10253521 · Received July 9, 2020

    Report

    Report Number
    1213809-2020-00452
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    May 19, 2020
    Report Date
    July 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059219
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES. D.10 RETURNED TO MANUFACTURER ON: 2020-07-21. INVESTIGATION SUMMARY: FOUR STRIPS OF 5 SAFETYGLIDE NEEDLES WERE RECEIVED AND VISUALLY EVALUATED. EACH STRIP OF 5 HAD PROGRESSIVELY LESS TOP WEB PRINT, WITH ONE STRIP MISSING ALMOST ALL INFORMATION ON THE WEB. FROM THE STRIPS THAT CONTAINED SOME INFORMATION IT WAS POSSIBLE TO DISCERN PARTIAL BATCH # 00024 WITH THE LAST TWO DIGITS LIKELY BEING 01. CATALOG NUMBER WAS CONFIRMED TO BE 305921. THIS INFORMATION WAS CROSS-REFERENCED WITH PRODUCTION TIMELINE TO VERIFY THAT THE BATCH # WAS HIGHLY LIKELY 0002401 FOR THIS PRODUCT. MISSING AND/OR ILLEGIBLE TOP WEB PRINT IS A REJECTABLE CONDITION PER PRODUCT SPECIFICATION. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. THE DEFECT WAS FOUND DURING THE MANUFACTURE OF THIS BATCH. PRODUCT WAS STOPPED, ADJUSTMENTS WERE MADE AND PRODUCT REQUALIFIED PER APPLICABLE AQL. HOWEVER, NO QUALITY NOTIFICATION WAS ISSUED. BATCH 0002401 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADJUSTMENTS TO PRINT HEADS WERE RECORDED IN THE DHR TO ADDRESS THE DEFECT THAT MATCHED THE ONE OBSERVED IN THE RETURNED CUSTOMER SAMPLES. THERE WERE 2 POTENTIAL ROOT CAUSES. EQUIPMENT FAILURE DURING PACKAGING PROCESS. THERE WAS A RECORDED ISSUE WITH THE TOP WEB PRINTER THAT WAS DETECTED DURING PRODUCTION. INSUFFICIENT CONTAINMENT OF DEFECT. REQUALIFICATION CRITERIA WILL BE TIGHTENED FOR POTENTIAL FUTURE INSTANCES OF TOP WEB PRINT DEFECTS. THE DUE DATE FOR THESE CORRECTIVE ACTIONS ARE 18SEP2020.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE THE LABEL IS DISCOVERED MISSING FROM BACK OF 10 PACKAGE WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INDIVIDUAL ITEMS ARE SUPPOSED TO HAVE LABEL INFO ON THE BACK PLASTIC WRAP AND WHEN RECEIVED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED. (B)(6) WAS USED AS A PLACE HOLDER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THE LABEL IS DISCOVERED MISSING FROM BACK OF 10 PACKAGE WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INDIVIDUAL ITEMS ARE SUPPOSED TO HAVE LABEL INFO ON THE BACK PLASTIC WRAP AND WHEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719173 BD SAFETYGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305921 UNKNOWN 30382903059219

    Patients

    Seq Age Sex Outcome Treatment
    1 Other