BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML SYRINGE LUER-LOK TIP

    MDR report key: 10106318 · Received June 1, 2020

    Report

    Report Number
    1213809-2020-00346
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    May 10, 2020
    Report Date
    July 8, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-06-18. H.6. INVESTIGATION SUMMARY: ONE PHOTO AND ONE 5ML SYRINGE IN A FULLY SEALED BLISTER PACK FROM BATCH 9070842 (P/N 309649) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS DAMAGE PRESENT AT THE BOTTOM OF THE PLUNGER ROD WITH PORTIONS OF THE RETAINING RINGS AND RIB MISSING. THE DAMAGE HAD A SHAVED APPEARANCE WITH A BUILDUP OF PLASTIC FIBERS ON THE EDGES AND SOME ORANGE DISCOLORATION. THE DAMAGE WAS REJECTABLE PER PRODUCT SPECIFICATION. THE SAMPLE WAS TESTED FOR MOLD WITH THE RESULTS INDICATING NO MOLD WAS PRESENT. THE POTENTIAL ROOT CAUSE FOR THE PLUNGER ROD DAMAGE IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT LIKELY THE PLUNGER ROD BECAUSE JAMMED WHEN ENTERING THE RAIL CAUSING THE ORANGE BELT TO SHEAR A PORTION OF THE PLUNGER ROD LEADING TO A BUILD-UP OF ORANGE PLASTIC FIBERS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9070842 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 5ML SYRINGE LUER-LOK¿ TIP EXPERIENCED FOREIGN MATTER CONTAMINATION/CORING WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLASTIPAK SYRINGE 5ML HAS MOLDS INSIDE THE SYRINGE THAT IS COLOR PINK WHICH IS STILL SEALED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD 5ML SYRINGE LUER-LOK¿ TIP EXPERIENCED FOREIGN MATTER CONTAMINATION/CORING WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLASTIPAK SYRINGE 5ML HAS MOLDS INSIDE THE SYRINGE THAT IS COLOR PINK WHICH IS STILL SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570552 BD 5ML SYRINGE LUER-LOK TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 9070842 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other