BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE INTEGRA 3ML W/NDL 23X1 RB

    MDR report key: 12145723 · Received July 9, 2021

    Report

    Report Number
    1213809-2021-00484
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 11, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    00382903052714
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-09-03. H6: INVESTIGATION SUMMARY ONE LOOSE 3ML INTEGRA SYRINGE (P/N 305271) AND SIX SEALED INTEGRA SYRINGES FROM BATCH #0002375 WERE RECEIVED. THE LOOSE SYRINGE WAS ACTIVATED AND APPEARED TO HAVE BEEN HEAVILY MANIPULATED AS EVIDENCED BY THE SPRING BEING OUTSIDE OF THE PLUNGER. NO VISUAL DEFECTS WERE OBSERVED. THE SEALED SAMPLES WERE VISUALLY EVALUATED AND FUNCTIONALLY TESTED FOR PLUNGER ROD COLLAPSE FORCE, HUB CUT FORCE, AND HUB CUT ENERGY. ONE SAMPLE WAS INADVERTENTLY DESTROYED DUE TO A TESTING APPARATUS MALFUNCTION. FOUR SAMPLES YIELDED ACCEPTABLE RESULTS. ONE SAMPLE WAS ACCEPTABLE FOR PLUNGER ROD COLLAPSE FORCE AND HUB CUT FORCE, BUT FAILED FOR EXCESS HUB CUT ENERGY, WHICH WAS NON-CONFORMING PER PRODUCT SPECIFICATION. THE PREMATURE COLLAPSE CONDITION WAS NOT OBSERVED IN THE SAMPLES RECEIVED. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE HUB CUT ENERGY IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #0002375 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 23X1 RB NEEDLE FRAGMENTS BROKE OFF INTO THE PATIENT'S SKIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THE SYRINGE RETRACTED PREMATURELY, CAUSING FRAGMENTS TO BREAK OFF INTO HIS SKIN.   VERBATIM: THE CUSTOMER STATES THAT THE SYRINGE WAS PARTIALLY EMBEDDED AROUND THE STOMACH. HE STATED THAT THE SYRINGE RETRACTED PREMATURELY, CAUSING FRAGMENTS TO BREAK OFF INTO HIS SKIN. CONSUMER STATED THAT HE WENT TO THE EMERGENCY ROOM AND HAD A CAT SCAN DONE OF THE LEG AND STOMACH AND NO NEEDLE FRAGMENTS WERE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 23X1 RB NEEDLE FRAGMENTS BROKE OFF INTO THE PATIENT'S SKIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THE SYRINGE RETRACTED PREMATURELY, CAUSING FRAGMENTS TO BREAK OFF INTO HIS SKIN.   VERBATIM: THE CUSTOMER STATES THAT THE SYRINGE WAS PARTIALLY EMBEDDED AROUND THE STOMACH. HE STATED THAT THE SYRINGE RETRACTED PREMATURELY, CAUSING FRAGMENTS TO BREAK OFF INTO HIS SKIN. CONSUMER STATED THAT HE WENT TO THE EMERGENCY ROOM AND HAD A CAT SCAN DONE OF THE LEG AND STOMACH AND NO NEEDLE FRAGMENTS WERE FOUND.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 23X1 RB NEEDLE FRAGMENTS BROKE OFF INTO THE PATIENT'S SKIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THE SYRINGE RETRACTED PREMATURELY, CAUSING FRAGMENTS TO BREAK OFF INTO HIS SKIN.   VERBATIM: THE CUSTOMER STATES THAT THE SYRINGE WAS PARTIALLY EMBEDDED AROUND THE STOMACH. HE STATED THAT THE SYRINGE RETRACTED PREMATURELY, CAUSING FRAGMENTS TO BREAK OFF INTO HIS SKIN. CONSUMER STATED THAT HE WENT TO THE EMERGENCY ROOM AND HAD A CAT SCAN DONE OF THE LEG AND STOMACH AND NO NEEDLE FRAGMENTS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043688 SYRINGE INTEGRA 3ML W/NDL 23X1 RB PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 0002375 00382903052714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention