BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA¿ NEEDLE ONLY 5/8 IN. RETRACTING NEEDLE

    MDR report key: 13415533 · Received February 1, 2022

    Report

    Report Number
    1213809-2022-00031
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 12, 2022
    Report Date
    July 25, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903053101
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305310 AND LOT NUMBER 0080062. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PR# (B)(4). FOLLOW UP REPORT FOR ADDITIONAL INFORMATION/CORRECTION. EVENT DETAILS WERE PROVIDED AFTER THE INITIAL MDR WAS SUBMITTED: TWO (B)(6) FEMALE PT WAS SEEN IN PEDIATRICIAN'S OFFICE ON (B)(6) 2022 FOR ROUTINE EXAM AND VACCINES. VACCINES WERE GIVEN WITHOUT PROBLEM. LATER, ON THE SAME EVENING, PT'S PARENTS CALLED PHYSICIAN OFFICE TO REPORT THAT THEY REMOVED A NEEDLE FROM THE CHILD'S THIGH. PHYSICIAN ASKED PARENTS TO BRING THE PT IN THAT EVENING FOR ASSESSMENT. THE CHILD DID NOT SUFFER INJURY. DUE TO THE LENGTH OF TIME THE NEEDLE WAS IN PT'S LEG, PHYSICIAN PRESCRIBED ANTIBIOTICS. X-RAYS WERE ALSO PERFORMED TO CONFIRM THE NEEDLE WAS COMPLETELY REMOVED. X-RAYS WERE CLEAR, A 25G 5/8" NEEDLE WAS REMOVED FROM THE PT'S LEG. ADD'L INFO RECEIVED FROM REPORTER ON 01/24/2022 FOR MW5106686. THIS REPORT CONTAINS THE INFO FOR THE SYRINGE USED IN CONJUNCTION WITH THE NEEDLE. CORRECTING PROCODE INFORMATION. RELATED REPORT NUMBER, MW5106686, WAS PROVIDED AFTER THE INITIAL MDR WAS SUBMITTED. ANNEX C CODE C19 - NO DEVICE PROBLEM FOUND, WAS ADDED AFTER SUPPLEMENTAL FOR DEVICE EVALUATION WAS SUBMITTED. ANNEX D CODE D14 - NO PROBLEM DETECTED, WAS ADDED AFTER SUPPLEMENTAL FOR DEVICE EVALUATION WAS SUBMITTED. CORRECTIONS AS PER ADDITIONAL INFORMATION: THE ADVERSE TYPE WAS INCORRECT IN THE INITIAL MDR. UPDATED ADVERSE TYPE TO REPORTED ISSUE IS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM. PRO CODE INFORMATION WAS INCORRECT IN THE INITIAL MDR. PRO CODE SHOULD BE FMI. THE TYPE OF REPORTABLE EVENT WAS INCORRECT IN THE INITIAL MDR. UPDATED TYPE OF REPORTABLE EVENT TO SERIOUS INJURY. ANNEX F CODE WAS INCORRECT IN THE INITIAL MDR. ANNEX F CODE SHOULD BE F12 - SERIOUS INJURY/ ILLNESS/ IMPAIRMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTEGRA¿ NEEDLE ONLY 5/8 IN. RETRACTING NEEDLE HAD THE NEEDLE BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " BD1-A NURSE AT (B)(6) WHILE ADMINISTRATING AT SHOT TO ON A CHILD THE NEEDLE BROKE OFF IN THE CHILD'S LEG."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTEGRA¿ NEEDLE ONLY 5/8 IN. RETRACTING NEEDLE HAD THE NEEDLE BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD1-A NURSE AT BAPTIST HEALTH SYSTEM WHILE ADMINISTRATING AT SHOT TO ON A CHILD THE NEEDLE BROKE OFF IN THE CHILD'S LEG."

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 03-JUL-2024 FROM MEDWATCH FORM: TWO (B)(6) FEMALE PT WAS SEEN IN PEDIATRICIAN'S OFFICE ON (B)(6) 2022 FOR ROUTINE EXAM AND VACCINES. VACCINES WERE GIVEN WITHOUT PROBLEM. LATER, ON THE SAME EVENING, PT'S PARENTS CALLED PHYSICIAN OFFICE TO REPORT THAT THEY REMOVED A NEEDLE FROM THE CHILD'S THIGH. PHYSICIAN ASKED PARENTS TO BRING THE PT IN THAT EVENING FOR ASSESSMENT. THE CHILD DID NOT SUFFER INJURY. DUE TO THE LENGTH OF TIME THE NEEDLE WAS IN PT'S LEG, PHYSICIAN PRESCRIBED ANTIBIOTICS. X-RAYS WERE ALSO PERFORMED TO CONFIRM THE NEEDLE WAS COMPLETELY REMOVED. X-RAYS WERE CLEAR, A 25G 5/8" NEEDLE WAS REMOVED FROM THE PT'S LEG. ADD'L INFO RECEIVED FROM REPORTER ON 01/24/2022 FOR MW5106686. THIS REPORT CONTAINS THE INFO FOR THE SYRINGE USED IN CONJUNCTION WITH THE NEEDLE. ADDITIONAL INFORMATION RECEIVED ON 26-JUN-2024, FOR MW5106686. CORRECTING PROCODE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504225 BD INTEGRA¿ NEEDLE ONLY 5/8 IN. RETRACTING NEEDLE ANTISTICK SYRINGE FMI BECTON DICKINSON MEDICAL SYSTEMS 305310 0080062 30382903053101
    976956 BD INTEGRA¿ NEEDLE ONLY 5/8 IN. RETRACTING NEEDLE ANTISTICK SYRINGE FMI BECTON DICKINSON MEDICAL SYSTEMS 305310 0080062 30382903053101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other