BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8890861 · Received August 13, 2019

    Report

    Report Number
    3003152976-2019-00532
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 24, 2019
    Report Date
    September 19, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1905258, 1905257, 1905228, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF EACH LOT WERE USED TO CONDUCT A LEAKAGE TEST. ALL PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. NO SAMPLE OR PICTURE HAS BEEN RECEIVED FOR INVESTIGATION. DHR OF LOT 1905258, 1905257 AND 1905228 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. TEN RETAINED SAMPLES OF 50LL LOT 1905258, TEN RETAINED SAMPLES OF 50LL LOT 1905257 AND TEN RETAINED SAMPLES OF 50LL LOT 1905228 ARE EVALUATED. UPON VISUAL INSPECTION OF THESE 30 SAMPLES, NO DAMAGE OR MOLDING DEFECT CAN BE OBSERVED IN ANY OF THEM THAT COULD CAUSE LEAKAGE. THE STOPPER IS CORRECTLY ASSEMBLED TO THE PLUNGER IN THE TEN SAMPLES. LEAK TEST IS CARRIED OUT WITH THE 30 RETAINED SAMPLES ACCORDING TO PROCEDURE PC-039 AND ISO 7886-1 ANNEX D. ALL OF THEM MEET ISO 7886-1 ANNEX D. THEY ARE DISASSEMBLED NOT OBSERVING ANY DAMAGE IN PLUNGER ROD THAT COULD HAVE CAUSED LEAKAGE. ACCORDING TO INSPECTION PLAN PROCEDURE JG-500, 200 UNITS ARE INSPECTED EVERY 2 PALLETS BY QUALITY CONTROL TEAM. IN ADDITION, FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED BY OPERATOR AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES (JG-301, JG-302, JG-303 AND JG-304). SINCE NO SAMPLE/PICTURE HAS BEEN RECEIVED AND NO MANUFACTURING DEFECT HAS BEEN FOUND IN RETAINING SAMPLES EVALUATED AND THEY MEET ISO 7886-1 ANNEX D, THE ROOT CAUSE OF THE ALLEGED DEFECT CANNOT BE DETERMINED. 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 QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON QDA LIMITS FOR THIS PRODUCT AND DEFECT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THERE IS LEAKAGE PAST THE PLUNGER WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECENTLY EXPERIENCED A RECURRING PROBLEM WITH THE 50ML BD SYRINGES, WHEREAS THE LIQUID IS FINDING ITS WAY PAST THE BUNG. AT FIRST WE THOUGHT IT MAY BE THE OPERATOR PULLING BACK TOO FAST, HOWEVER THIS HAS NOW HAPPENED ON NUMEROUS OCCASIONS WITH DIFFERENT OPERATORS. THE BATCH NUMBERS I AM CONCERNED ABOUT ARE : 1905257 , 1905258 AND 1905228.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1905228. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-13. MEDICAL DEVICE LOT #: 1905257. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-24. MEDICAL DEVICE LOT #: 1905258. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-05-29. " 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 DURING USE THERE IS LEAKAGE PAST THE PLUNGER WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECENTLY EXPERIENCED A RECURRING PROBLEM WITH THE 50ML BD SYRINGES, WHEREAS THE LIQUID IS FINDING ITS WAY PAST THE BUNG. AT FIRST WE THOUGHT IT MAY BE THE OPERATOR PULLING BACK TOO FAST, HOWEVER THIS HAS NOW HAPPENED ON NUMEROUS OCCASIONS WITH DIFFERENT OPERATORS. THE BATCH NUMBERS I AM CONCERNED ABOUT ARE : 1905257, 1905258, 1905228.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684094 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other