BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA 3 ML SYRINGE W/ DETACHABLE NEEDLE

    MDR report key: 9362810 · Received November 22, 2019

    Report

    Report Number
    1213809-2019-01170
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 6, 2019
    Report Date
    January 29, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052722
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY ONE SHARPS CONTAINER WAS RECEIVED, CONTAINING A LOOSE INTEGRA SYRINGE WITH NEEDLE ATTACHED AND AN OPENED BLISTER PACKAGE FROM BATCH #6021826 (P/N 305272). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS USED WITH MEDICATION RESIDUE IN THE FLUID PATH. THE STOPPER WAS AT THE BOTTOM OUT POSITION AND THE PLUNGER ROD FLUSH WITH THE BARREL SHROUD. THE RETRACTION MECHANISM WAS OBSERVED TO HAVE BEEN ACTIVATED. THE CANNULA WAS NOT OBSERVED TO BE INSIDE THE NEEDLE SHIELD. THE NEEDLE HUB ASSEMBLY WAS CAREFULLY REMOVED. THE METAL CANNULA WAS FOUND TO BE INSIDE THE INNER PLUNGER ROD. THE RETRACTION APPEARS TO HAVE WORKED AS DESIGNED WITH NO DEFECTS OBSERVED IN THE SAMPLE RECEIVED. THE PRODUCT PERFORMED AS DESIGNED AND NEEDLE RETRACTED CORRECTLY AS EVIDENCED BY THE CANNULA BEING FOUND IN THE BARREL OF THE RETURNED SAMPLE. NO DEFECTS CONFIRMED IN THE RETURNED SAMPLE. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL NO.: 305272 BATCH NO.: 6021826 IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ 3 ML SYRINGE W/ DETACHABLE NEEDLE ADMINISTERING A TESTOSTERONE INJECTION THE CUSTOMER STATED THE NEEDLE DID NOT RETRACT INTO THE BARREL AND INSTEAD BROKE OFF IN HIS BUTT AND HE'S SURE IT BROKE BECAUSE HE CAN FEEL IT IN THERE. LATER ON A PHONE CALL ON (B)(6) 2019 HE NOTICED THE SYRINGE RETRACTS THE NEEDLE AND THAT IT HAPPENED SO FAST HE DID NOT REALIZE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER CALLED TO LET US KNOW THAT HE USED THE OTHER SYRINGE AND NOTICED THE SYRINGE RETRACTS THE NEEDLE. HE OPENED UP THE SYRINGE BARREL AND NOTICED THE NEEDLE IS THERE, IT HAPPENED SO FAST HE DID NOT REALIZE THE SYRINGE RETRACTED THE NEEDLE. CONSUMER REPORTED: NEEDLE BROKE OFF IN HIS BUTT WHEN TAKING HIS TESTOSTERONE INJECTION STATED, IT DID NOT RETRACT BACK INTO THE BARREL BECAUSE HE CAN FEEL IT IN HIS BUTT STATED, HE DID NOT GO TO DOCTOR AND HE IS SURE IT BROKE OFF IN HIS BUTT STATED, HE GOING TO MAKE AN APPOINTMENT TO SEE A DOCTOR INCIDENT DATE: (B)(6) 2019. LOT: 6021826 ITEM: 305272 EXPIRATION DATE: 2020-12.

    Additional Manufacturer Narrative · 1

    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

    MATERIAL NO.: 305272, BATCH NO.: 6021826. IT WAS REPORTED THAT DURING USE OF THE BD INTEGRA¿ 3 ML SYRINGE W/ DETACHABLE NEEDLE ADMINISTERING A TESTOSTERONE INJECTION THE CUSTOMER STATED THE NEEDLE DID NOT RETRACT INTO THE BARREL AND INSTEAD BROKE OFF IN HIS BUTT AND HE'S SURE IT BROKE BECAUSE HE CAN FEEL IT IN THERE. LATER ON A PHONE CALL ON (B)(6) 2019 HE NOTICED THE SYRINGE RETRACTS THE NEEDLE AND THAT IT HAPPENED SO FAST HE DID NOT REALIZE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER CALLED TO LET US KNOW THAT HE USED THE OTHER SYRINGE AND NOTICED THE SYRINGE RETRACTS THE NEEDLE. HE OPENED UP THE SYRINGE BARREL AND NOTICED THE NEEDLE IS THERE, IT HAPPENED SO FAST HE DID NOT REALIZE THE SYRINGE RETRACTED THE NEEDLE. CONSUMER REPORTED: NEEDLE BROKE OFF IN HIS BUTT WHEN TAKING HIS TESTOSTERONE INJECTION. STATED, IT DID NOT RETRACT BACK INTO THE BARREL BECAUSE HE CAN FEEL IT IN HIS BUTT. STATED, HE DID NOT GO TO DOCTOR AND HE IS SURE IT BROKE OFF IN HIS BUTT. STATED, HE IS GOING TO MAKE AN APPOINTMENT TO SEE A DOCTOR. INCIDENT DATE: (B)(6) 2019. LOT: 6021826, ITEM: 305272, EXPIRATION DATE: 2020-12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161005 BD INTEGRA 3 ML SYRINGE W/ DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305272 6021826 30382903052722

    Patients

    Seq Age Sex Outcome Treatment
    1 Other