BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP DISPOSABLE SYRINGE

    MDR report key: 13529687 · Received February 14, 2022

    Report

    Report Number
    1213809-2022-00070
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    February 1, 2022
    Report Date
    April 20, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1118091. MEDICAL DEVICE EXPIRATION DATE: 2026-03-31. DEVICE MANUFACTURE DATE: 2021-04-28. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: 1041512. MEDICAL DEVICE EXPIRATION DATE: 2021-02-21. DEVICE MANUFACTURE DATE: 2021-04-10. MEDICAL DEVICE LOT #: 0183088. MEDICAL DEVICE EXPIRATION DATE: 2020-07-30. DEVICE MANUFACTURE DATE: 2020-07-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1118091. MEDICAL DEVICE EXPIRATION DATE: 2026-03-31. DEVICE MANUFACTURE DATE: 2021-04-28. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: 1041512. MEDICAL DEVICE EXPIRATION DATE: 2021-02-21. DEVICE MANUFACTURE DATE: 2021-04-10. MEDICAL DEVICE LOT #: 0183088. MEDICAL DEVICE EXPIRATION DATE: 2020-07-30. DEVICE MANUFACTURE DATE: 2020-07-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. THREE 3ML LUER-LOCK SYRINGES (P/N 309657) WERE RECEIVED AND EVALUATED. EACH SYRINGE CAME WITH A LENGTH OF TUBING, A CONNECTOR AND A TOP WEB SLIP FROM BATCH NUMBERS 0183088, 1041512, AND 1118091. EACH SAMPLE WAS VISUALLY INSPECTED AND NO DAMAGE WAS FOUND. EACH SAMPLE WAS LEAK TESTED AND ALL THREE SAMPLES WERE ACCEPTABLE WITH NO LEAKAGE OCCURRING. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. SINCE THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP DISPOSABLE SYRINGE, THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CONSUMER LEAKAGE. THE LEAKING WAS NOTED WITH MEDICATIONS PREPARED IN THE PHARMACY WITH 3ML BD SYRINGES. I HAVE ATTACHED PREFILLED 3ML MONOJECT SALINE SYRINGES AND THEY ARE NOT LEAKING AT THE CONNECTOR. THERE WERE 3 DIFFERENT LOT #S OF THE BD SYRINGES IN THE PHARMACY. THEY ARE 1118091, 1041512, 0183088. SINCE THE MEDICATIONS CAME UP ALREADY IN THE SYRINGES, I DO NOT KNOW WHICH ONES WERE USED. WE ALSO HAVE 3ML SYRINGES IN OUR UNIT BUT THEY ARE TOTALLY DIFFERENT LOT NUMBERS. THE OCCURRENCES ARE HAPPENING WHEN THE NURSE FIRST CONNECTS THE BD MEDICATION SYRINGE TO THE CONNECTOR ON THE TUBING. THE LEAKING IS OCCURRING WHEN THE SYRINGE IS ATTACHED TO THE NEW TUBING

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP DISPOSABLE SYRINGE, THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CONSUMER LEAKAGE. THE LEAKING WAS NOTED WITH MEDICATIONS PREPARED IN THE PHARMACY WITH 3ML BD SYRINGES. I HAVE ATTACHED PREFILLED 3ML MONOJECT SALINE SYRINGES AND THEY ARE NOT LEAKING AT THE CONNECTOR. THERE WERE 3 DIFFERENT LOT #S OF THE BD SYRINGES IN THE PHARMACY. THEY ARE 1118091, 1041512, 0183088. SINCE THE MEDICATIONS CAME UP ALREADY IN THE SYRINGES, I DO NOT KNOW WHICH ONES WERE USED. WE ALSO HAVE 3ML SYRINGES IN OUR UNIT BUT THEY ARE TOTALLY DIFFERENT LOT NUMBERS. THE OCCURRENCES ARE HAPPENING WHEN THE NURSE FIRST CONNECTS THE BD MEDICATION SYRINGE TO THE CONNECTOR ON THE TUBING. THE LEAKING IS OCCURRING WHEN THE SYRINGE IS ATTACHED TO THE NEW TUBING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP DISPOSABLE SYRINGE, THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CONSUMER LEAKAGE. THE LEAKING WAS NOTED WITH MEDICATIONS PREPARED IN THE PHARMACY WITH 3ML BD SYRINGES. I HAVE ATTACHED PREFILLED 3ML MONOJECT SALINE SYRINGES AND THEY ARE NOT LEAKING AT THE CONNECTOR. THERE WERE 3 DIFFERENT LOT #S OF THE BD SYRINGES IN THE PHARMACY. THEY ARE 1118091, 1041512, 0183088. SINCE THE MEDICATIONS CAME UP ALREADY IN THE SYRINGES, I DO NOT KNOW WHICH ONES WERE USED. WE ALSO HAVE 3ML SYRINGES IN OUR UNIT BUT THEY ARE TOTALLY DIFFERENT LOT NUMBERS. THE OCCURRENCES ARE HAPPENING WHEN THE NURSE FIRST CONNECTS THE BD MEDICATION SYRINGE TO THE CONNECTOR ON THE TUBING. THE LEAKING IS OCCURRING WHEN THE SYRINGE IS ATTACHED TO THE NEW TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670560 BD LUER-LOK¿ TIP DISPOSABLE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 SEE H.10. 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown