BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK 30 ML SYRINGE

    MDR report key: 11712761 · Received April 23, 2021

    Report

    Report Number
    3003152976-2021-00218
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 22, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1911733 MEDICAL DEVICE EXPIRATION DATE: 2024-10-31 DEVICE MANUFACTURE DATE: 2019-11-28. MEDICAL DEVICE LOT #: 1912222 MEDICAL DEVICE EXPIRATION DATE: 2024-11-30 DEVICE MANUFACTURE DATE: 2019-12-10. MEDICAL DEVICE LOT #: 2006209 MEDICAL DEVICE EXPIRATION DATE: 2025-05-31 DEVICE MANUFACTURE DATE: 2020-07-01. INVESTIGATION SUMMARY: FOUR SAMPLES FROM LOT 2006209 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION, NO SAMPLES OF LOT 1911733 AND 1912222 WERE RECEIVED. THROUGH VISUAL INSPECTION OF THE PRODUCT RETURNED, A SMALL BLACK DOT NEAR THE BARREL EDGE WAS OBSERVED. WE WERE ABLE TO REMOVE THE SUBSTANCE AND IT WAS DETERMINED THE STAIN IS INK FROM THE MARKING PROCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOTS 2006209, 1911733 AND 1912222, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS FOR LOTS 1911733 AND 1912222 , HOWEVER, ONE ANNOTATION RELATED TO THIS EVENT WAS IDENTIFIED DURING PRODUCTION OF LOT 2006209. DURING THE MARKING PROCESS, A FAILURE WAS DETECTED RELATED TO A MALADJUSTMENT IN THE MARKING MACHINE WHICH RESULTED IN THE INK NOT BEING CORRECTLY TRANSFERRED ONTO THE BARREL, PRINTING THE DOT AS SEEN IN THE SAMPLES RETURNED. THE MECHANICAL TEAM REPAIRED THE FAILURE AND IMPACTED UNITS WERE SCRAPPED. IT WAS DETERMINED THE ISSUE REPORTED IS RELATED TO THIS MALFUNCTION. WE HAVE NOTIFIED MANUFACTURING PERSONNEL OF YOUR EXPERIENCE TO INCREASE AWARENESS OF THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. INVESTIGATION CONCLUSION: IT HAS BEEN RECEIVED FOUR UNUSED SAMPLES FROM CUSTOMER OF 30LL LOT. 2006209 REF.(B)(4). UPON VISUAL INSPECTION OF THE SAMPLES IT CAN BE OBSERVED THE FOUR SYRINGES HAVE A SMALL BLACK SUBSTANCE IN THE BARREL ALONG CERO STROKE, NEAR THE BARREL EDGE. THIS BLACK SUBSTANCE CAN BE REMOVED FROM THE SURFACE OF THE SYRINGE, SUGGESTING THE ORIGIN OF IT IS INK FROM THE MARKING PROCESS. DHR FOR LOT 2006209 HAS BEEN REVIEWED FINDING A DEVIATION REGARDING MARKING ISSUES. DURING MARKING PROCESS, SCALE IS PRINTED IN THE BARREL WITH SILK. THE FAILURE IN THIS PROCESS COULD HAVE CAUSED THE DEFECT OF THE SYRINGE AFFECTED. THE INK WAS NOT CORRECTLY TRANSFERRED TO THE BARREL DUE TO A MALADJUSTMENT IN THE MARKING MACHINE, PRINTING THIS BLACK DOT SEEN IN THE CLAIMED DEVICE. DHR FOR LOTS 1912222 AND 1911733 HAVE BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT ONCE DETECTED MECHANICAL TEAM REPAIRED THE FAILURE AND DEFECTIVE SAMPLES FOUND WERE REJECTED TO SCRAP. 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. BASED ON ALL OUR STRINGENT IN ¿PROCESS INSPECTION PLAN, WE ARE CERTAIN THAT THIS SHOULD BE AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY BASED ON NO QUALITY NOTIFICATION WAS OPENED DURING MANUFACTURING PROCESS OF THIS LOT. THE INCIDENT IS REPORTED TO MANUFACTURING AREA STAFF. 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. ACCORDING TO FAILURE IDENTIFIED IN THE DHR, WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH A NO CORRECT TRANSFERENCE OF THE INK TO THE BARREL DURING MARKING PROCESS. BASED ON ALL THE PREVENTIVE MEASURES AND OUR STRINGENT IN ¿PROCESS INSPECTION PLAN, WE ARE CERTAIN THAT THIS SHOULD BE AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY BASED ON NO QUALITY NOTIFICATION WAS OPENED DURING MANUFACTURING PROCESS OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGES EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA/NEEDLE/SYRINGE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS PRESENCE OF AN EXTERNAL BLACK DOT ON THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612292 BD PLASTIPAK LUER-LOK 30 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1