BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 10973454 · Received December 9, 2020

    Report

    Report Number
    1213809-2020-00880
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 11, 2020
    Report Date
    January 14, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059035
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: RETURNED TO MANUFACTURER ON: 2021-01-05. H6: INVESTIGATION SUMMARY: TWO OPENED 3ML SAFETYGLIDE COMBOS IN BLISTER PACKS FROM BATCH 9360282 (P/N 305905) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED BOTH HUBS OF THE NEEDLE ASSEMBLIES HAD LARGE CRACKS EXTENDING FROM THE OPENING PAST THE CONNECTION OF THE SAFETY SHIELD. THE DAMAGE WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR CRACKED HUB DEFECT IS ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. THE SAMPLES AND PHOTOS WERE FORWARDED TO THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. POTENTIAL ROOT CAUSE IS THAT WHILE ASSEMBLING THE NEEDLE HUB INTO THE ASSEMBLY FIXTURE, THE NEEDLE HUB WAS NOT PROPERLY CENTERED INDUCING THE CRACK OBSERVED IN THE SAMPLES. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 ATTACHED NEEDLES ON THE BD SAFETYGLIDE¿ INSULIN SYRINGES WERE BROKEN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE BROKEN"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: PISTON SYRINGE. MEDICAL DEVICE TYPE: FMF. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980580 (SYRINGE). PMA / 510(K)#: K951254 (NEEDLE). 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 2 ATTACHED NEEDLES ON THE BD SAFETYGLIDE¿ INSULIN SYRINGES WERE BROKEN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE BROKEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441266 BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305903 UNKNOWN 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1