BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE

    MDR report key: 10605911 · Received September 30, 2020

    Report

    Report Number
    3003152976-2020-00419
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    August 4, 2020
    Report Date
    November 7, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN CORRECTED: G.5 DATE RECEIVED BY MANUFACTURER: 2020-09-16.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE HAD FOREIGN MATTER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INK SPOTS ON SYRINGES. BD SYRINGES (IN PARTICULAR THE 30ML SYRINAGES) HAVE HAD LOTS OF INK SPOTS ON THEM (MULTIPLE PACKS). THIS MAKES IT QUITE DIFFICULT TO DIFFERENTIATE FROM A BUNG WHEN SIMPLY VIEWING THE FINISHED PRODUCT. SYRINGES WE RECEIVED THAT CLEARLY HAS HAD SOME INK PRINTING ISSUES.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1910729, MEDICAL DEVICE EXPIRATION DATE: 2024-09-30, DEVICE MANUFACTURE DATE: 2019-10-21, MEDICAL DEVICE LOT #: 2001238, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-08. DATE RECEIVED BY MANUFACTURER: BD WAS INITIALLY MADE AWARE OF THIS COMPLAINT ON (B)(6) 2020. AT THAT TIME, BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER, IT WAS EVALUATED AS A NON-REPORTABLE INCIDENT. ADDITIONAL INFORMATION WAS LATER RECEIVED ON 2020-09-18 THAT CHANGED THE REPORTABILITY DETERMINATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS COMPLAINT IS NOW CONSIDERED TO BE AN MDR REPORTABLE INCIDENT. (B)(4). INVESTIGATION SUMMARY: TWO PHOTOS ALONG WITH TWO SAMPLES OF LOT 1910729, AND ONE SAMPLE OF LOT 2001238 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTING THE PRODUCT, A MARKING ISSUE WAS IDENTIFIED ON THE SAMPLE OF LOT 2001238 AND INK STAINS WERE OBSERVED ON ONE SAMPLE OF LOT 1910729. THE SECOND SAMPLE OF LOT 1910729 WAS FURTHER EVALUATED AND FOUND TO HAVE EMBEDDED POLYPROPYLENE MATERIAL WITHIN THE BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOTS 1910729 AND 2001238, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING MANUFACTURING FOR LOT 1910729 IN RELATION TO THE EMBEDDED MATERIAL, HOWEVER, THERE WAS A MAINTENANCE ORDER THAT COULD HAVE CONTRIBUTED TO THE INK STAINING. WE ALSO IDENTIFIED ONE ANNOTATION THAT COULD BE RELATED TO INK STAINS FOR LOT 2001238. DURING THE MARKING PROCESS FOR LOT 1910729, AN INCIDENT WAS DETECTED IN THE MARKING MACHINE RELATED TO THE MISALIGNMENT OF THE POSITION SYSTEM THAT GUIDES THE BARREL DURING THE INK TRANSFER, LIKELY RESULTING IN INK SPOTS ON THE BARREL AS SEEN IN THE PRODUCT EVALUATED. DURING THE MARKING PROCESS FOR LOT 2001238, A FAILURE WAS DETECTED IN THE FLAMING SYSTEM THAT ENSURES THE PROPER TRANSFER OF THE INK ONTO THE BARREL. BOTH INCIDENTS WERE REPAIRED BY THE MECHANICAL TEAM ONCE THE ISSUES WERE IDENTIFIED. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE FOR THE EMBEDDED MATERIAL, POLYPROPYLENE PARTICLES CAN GENERATE DURING THE MOLDING PROCESS AND BECOME INJECTED INTO THE MOLD OF THE PIECE. INJECTION MACHINES ARE RAN BEFORE USE TO REMOVE ANY PARTICLES AND ARE ROUTINELY CLEANED ACCORDING TO PROCEDURE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED IN ORDER TO INCREASE AWARENESS OF THIS MATTER AND A WAS INITIATED TO REDUCE ANY REOCCURRENCE. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ACCORDING TO ISSUES IDENTIFIED DURING MANUFACTURING PROCESS OF BOTH LOTS, WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH FAILURES IN MARKING MACHINE AND FAILURE IN MOLDING PROCESS. RATIONALE: CORRECTIVE ACTION IS OPEN UNDER PROJECT#(B)(4) TO INSTALL A VISION SYSTEM IN MARKING MACHINE THAT DETECT THESE DEFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE HAD FOREIGN MATTER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INK SPOTS ON SYRINGES. BD SYRINGES (IN PARTICULAR THE 30 ML SYRINAGES) HAVE HAD LOTS OF INK SPOTS ON THEM (MULTIPLE PACKS). THIS MAKES IT QUITE DIFFICULT TO DIFFERENTIATE FROM A BUNG WHEN SIMPLY VIEWING THE FINISHED PRODUCT. SYRINGES WE RECEIVED THAT CLEARLY HAS HAD SOME INK PRINTING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069058 BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other