BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8617749 · Received May 16, 2019

    Report

    Report Number
    1213809-2019-00544
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052746
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 THE NEEDLE RETRACTED PREMATURELY AND WAS THOUGHT TO HAVE COME OUT AT INJECTION SITE WHICH LED TO MEDICAL INTERVENTION WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CONSUMER THOUGHT THAT THE NEEDLE MIGHT HAVE BROKEN OFF IN THEIR BUTTOCKS. VERBATIM STATES, "FROM PHONE CALL ON (B)(6) 2019 14:39:14: I CALLED PHARMACIST BACK AND ASKED HER TO HAVE CONSUMER CONTACT US TO PROVIDE MAILING ADDRESS. PHARMACIST STATED THAT SHE DOES NOT THINK THE CONSUMER WILL PURSUE ANYTHING, SAID SHE SEEMED TO BE RELIEVED WHEN SHE DEMONSTRATED HOW THE INTEGRA SYRINGE WORKS. PHARMACIST REPORTED ON BEHALF OF CONSUMER, THAT THE INTEGRA SYRINGE NEEDLE BROKE OFF INTO THE CONSUMER'S BUTTOCKS DURING INJECTION, STATED THAT THE CONSUMER WENT TO THE EMERGENCY ROOM TO HAVE THE NEEDLE REMOVED. WHILE ON THE PHONE, THE CONSUMER'S SPOUSE WALKED INTO THE PHARMACY AND REPORTED THAT HER HUSBAND WAS TAKEN BY AMBULANCE TO THE ER, AN ULTRASOUND WAS DONE AND THE NEEDLE WAS NOT FOUND. CONSUMER WAS NOT AWARE THAT THE INTEGRA SYRINGE IS RETRACTABLE, SHE WILL BE SENDING THE SAMPLE FOR EVALUATION. NO INJURY OR DISCOMFORT ALTHOUGH CONSUMER STATES THAT THERE IS PAIN WHEN THE INJECTION SITE IT TOUCHED. PROBLEM OCCURRED THIS MORNING ON ((B)(6) 2023), LOT # 8002924, EXP 12-31-2022, PRODUCT # 305274. CONSUMER IS ALSO SENDING RECEIPT FOR REFUND, WILL NO LONGER USE INTEGRA SYRINGES.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE RETRACTED PREMATURELY AND WAS THOUGHT TO HAVE COME OUT AT INJECTION SITE WHICH LED TO MEDICAL INTERVENTION WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CONSUMER THOUGHT THAT THE NEEDLE MIGHT HAVE BROKEN OFF IN THEIR BUTTOCKS. VERBATIM STATES, "FROM PHONE CALL ON (B)(6) 2019 14:39:14: I CALLED PHARMACIST BACK AND ASKED HER TO HAVE CONSUMER CONTACT US TO PROVIDE MAILING ADDRESS. PHARMACIST STATED THAT SHE DOES NOT THINK THE CONSUMER WILL PURSUE ANYTHING, SAID SHE SEEMED TO BE RELIEVED WHEN SHE DEMONSTRATED HOW THE INTEGRA SYRINGE WORKS. PHARMACIST REPORTED ON BEHALF OF CONSUMER, THAT THE INTEGRA SYRINGE NEEDLE BROKE OFF INTO THE CONSUMER'S BUTTOCKS DURING INJECTION, STATED THAT THE CONSUMER WENT TO THE EMERGENCY ROOM TO HAVE THE NEEDLE REMOVED. WHILE ON THE PHONE, THE CONSUMER'S SPOUSE WALKED INTO THE PHARMACY AND REPORTED THAT HER HUSBAND WAS TAKEN BY AMBULANCE TO THE ER, AN ULTRASOUND WAS DONE AND THE NEEDLE WAS NOT FOUND. CONSUMER WAS NOT AWARE THAT THE INTEGRA SYRINGE IS RETRACTABLE, SHE WILL BE SENDING THE SAMPLE FOR EVALUATION. NO INJURY OR DISCOMFORT ALTHOUGH CONSUMER STATES THAT THERE IS PAIN WHEN THE INJECTION SITE IT TOUCHED. PROBLEM OCCURRED THIS MORNING ((B)(6) "2019"), LOT # 8002924, EXP 12-31-2022, PRODUCT # 305274. CONSUMER IS ALSO SENDING RECEIPT FOR REFUND, WILL NO LONGER USE INTEGRA SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408008 BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 8002924 30382903052746

    Patients

    Seq Age Sex Outcome Treatment
    1 Other