BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE DETACHABLE NEEDLE

    MDR report key: 10570077 · Received September 22, 2020

    Report

    Report Number
    1213809-2020-00647
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    August 13, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096238
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-10-14. H6: INVESTIGATION SUMMARY ONE 1ML SYRINGE IN A FULLY SEALED BLISTER PACK FROM BATCH 0073306 (P/N 309623) WAS RECEIVED AND EVALUATED. THE SHIELD WAS REMOVED, AND THE CANNULA WAS VISUALLY INSPECTED UNDER 10X MAGNIFICATION. BASED ON THE VERBATIM, IT APPEARED MEDICATION CAME OUT OF THE INJECTION SITE AFTER USE AND NOT FROM THE SYRINGE ITSELF. THEREFORE, LEAKAGE TESTING ON THE DEVICE IS NOT APPLICABLE. THE SAMPLE WAS FORWARDED TO THE NEEDLE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED TO THE NEEDLE ASSEMBLY, NO DAMAGES WERE OBSERVED. THEN THE NEEDLE WAS INSPECTED UNDER A 30X MICROSCOPE. THERE WAS NO DAMAGE, BEVELS WERE GOOD, ETCH WAS GOOD. NO DEFECTIVE GRIND, NO HOOKS WERE OBSERVED. AFTER THAT THE NEEDLE ASSEMBLY WAS CONNECTED TO 10ML SYRINGE WITH SALINE SOLUTION. NO LEAKAGE WAS OBSERVED. BASED ON THE INVESTIGATION CARRIED OUT AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. FURTHERMORE, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICATION LEAKED FROM THE BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RETURNED CONSUMER'S PHONE CALL FROM VOICEMAIL THAT WAS RECEIVED. CONSUMER STATED SHE HAS USED ITEM # 305945 FOR YEARS AND RECENTLY HER PHARMACY ADVISED HER THEY WILL NOT BE CARRYING THAT PRODUCT AND THEY PROVIDED HER ITEM #309623. CONSUMER STATED THE NEW SYRINGES ARE VERY PAINFUL DURING HER INJECTIONS. STATED WHEN REMOVING THE NEEDLE FROM HER INJECTION SITE SOMETIMES THE MEDICATION COMES OUT WITH IT. SENDING CONSUMER REPLACEMENT TO HER LOCAL PHARMACY."

    Additional Manufacturer Narrative · 1

    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 MEDICATION LEAKED FROM THE BD¿ TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE¿ DETACHABLE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RETURNED CONSUMER'S PHONE CALL FROM VOICEMAIL THAT WAS RECEIVED. CONSUMER STATED SHE HAS USED ITEM # 305945 FOR YEARS AND RECENTLY HER PHARMACY ADVISED HER THEY WILL NOT BE CARRYING THAT PRODUCT AND THEY PROVIDED HER ITEM # #309623. CONSUMER STATED THE NEW SYRINGES ARE VERY PAINFUL DURING HER INJECTIONS. STATED WHEN REMOVING THE NEEDLE FROM HER INJECTION SITE SOMETIMES THE MEDICATION COMES OUT WITH IT. SENDING CONSUMER REPLACEMENT TO HER LOCAL PHARMACY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035675 BD TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE DETACHABLE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309623 0073306 30382903096238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other