BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿

    MDR report key: 7354470 · Received March 20, 2018

    Report

    Report Number
    3003152976-2018-00089
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 23, 2018
    Report Date
    February 24, 2018
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION RESULTS: SUMMARY: THREE UNUSED 10ML LL SAMPLES WITH AN OPEN BLISTER AND FOUR PICTURES WERE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE FOUR PICTURES RECEIVED, EXCESS OF SILICONE INSIDE THE SYRINGES WAS VERIFIED. UPON VISUAL INSPECTION OF THE SAMPLES RECEIVED, NO EXCESS OF SILICONE WAS OBSERVE INSIDE THE BARREL AND TIP. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. MEDICAL GRADE SILICONE IS EMPLOYED DURING SYRINGE THE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS. THIS DEFECT HAS BEEN PRODUCED BY A FAILURE OF THE SILICONE SPRAYER. DURING THE MANUFACTURING PROCESS, SILICONE CONTENT IS CHECKED PER LOT ACCORDING TO PROCEDURE. ON CHECKING THE RESULTS DURING THE MANUFACTURING PROCESS OF LOT 171022 THEY MEET SPECIFICATION LIMITS. SILICONE CONTENT TEST WAS DONE WITH THE THREE SAMPLES RECEIVED AND THE RESULTS MET SPECIFICATION LIMITS. BASED UPON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT IS RELATED TO THE MANUFACTURING PROCESS AND THE APPROPRIATE PERSONNEL HAS BEEN NOTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CONCLUSION: THREE UNUSED SAMPLES OF 10LL WITH AN OPEN BLISTER LOT 1710022 AND FOUR PICTURES WERE RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE FOUR PICTURES RECEIVED, IT CAN BE OBSERVED EXCESS OF SILICONE INSIDE THE SYRINGES. UPON VISUAL INSPECTION OF THE SAMPLES RECEIVED, NO EXCESS OF SILICONE CAN BE OBSERVED E INSIDE THE BARREL AND TIP. DHR OF LOT 1701022 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. SILICONE IS EMPLOYED DURING SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED TO THIS KIND OF PRODUCTS ACCORDING TO (B)(4) (MAX.VALUE 0.25MG/CM2). THIS DEFECT HAS BEEN PRODUCED BY A FAILURE OF THE SILICONE SPRAYER. DURING MANUFACTURING PROCESS SILICONE CONTENT IS CHECKED PER LOT ACCORDING TO PROCEDURE FOLLOWING METHOD IN PROCEDURE. ON CHECKING THE RESULTS DURING MANUFACTURING PROCESS OF LOT 171022 THEY MEET SPECIFICATION LIMITS. SILICONE CONTENT TEST IS DONE WITH THE 3 SAMPLES RECEIVED AND RESULTS MEET SPECIFICATION LIMITS PREVIOUSLY MENTIONED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. ROOT CAUSE: UPON VISUAL INSPECTION OF THE FOUR PICTURES RECEIVED, IT CAN BE OBSERVED EXCESS OF SILICONE INSIDE THE SYRINGES. UPON VISUAL INSPECTION OF THE SAMPLES RECEIVED, NO EXCESS OF SILICONE CAN BE OBSERVED INSIDE THE BARREL AND TIP. DEFECT OBSERVED IN PICTURES RECEIVED HAS BEEN PRODUCED BY A FAILURE OF THE SILICONE SPRAYER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER ¿VISIBLE LUBRICANT¿ WAS FOUND IN THE FLUID PATH OF A BD PLASTIPAK¿ 10MLHYPODERMIC SYRINGE LUER LOK¿. THERE WAS NO EXPOSURE, INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195014 BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ HYPODERMIC SYRINGE FMF BECTON DICKINSON, S.A. 1710022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other