BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 9946433 · Received April 9, 2020

    Report

    Report Number
    1213809-2020-00241
    Event Type
    Malfunction
    Date Received
    April 9, 2020
    Date of Event
    November 25, 2019
    Report Date
    May 11, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. D.10. RETURNED TO MANUFACTURER ON: 4/30/2020. H.6. INVESTIGATION: ONE PHOTO OF THE BOTTOM VIEW OF A SEALED BLISTER PACK WITH A 1ML SYRINGE INSIDE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS SMUDGED PRINT BETWEEN THE 0.25ML AND 0.4ML MARKING. SOME OF THE GRAD LINES WERE MISSING MORE THAN 50%, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. ONE SEALED PACKAGED 1ML LL SYRINGE WAS RECEIVED, CONFIRMED TO BE FROM BATCH #8338914 (P/N 309628). A VISUAL EVALUATION WAS PERFORMED, WHICH WAS CONSISTENT WITH PHOTO EVALUATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8338914 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 BD 1ML SYRINGE LUER-LOK¿ TIP HAD INCOMPLETE SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH NO.: 8338914. IT WAS REPORTED THAT THE SEALED SYRINGE HAD INCOMPLETE SCALE MARKINGS ON ITS BARREL. PER SCAR 19-1421: ON 25NOV2019, DURING A REQUESTED EXAMINATION OF 120 RETAIN CARTONS OF EYLEA VIAL LABELED DRUG PRODUCT (LDP) BY WAREHOUSE AND LOGISTICS (WHL), ONE SYRINGE WAS FOUND TO HAVE INCOMPLETE MARKINGS ON ITS BARREL. THE CARTON CONTAINING THE SYRINGE WITH INCOMPLETE MARKINGS WILL REMAIN INTACT WITH THE OTHER 119 CARTONS IN A BIN. THE OUTER CARTON WAS MARKED WITH A DEFECT DESCRIPTION FOR EASY RETRIEVAL. THIS LOT OF EYLEA VIAL LDP WILL REMAIN STORED AT 2-8C UNTIL FUTURE DISPOSAL BY WHL.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO OF THE BOTTOM VIEW OF A SEALED BLISTER PACK WITH A 1ML SYRINGE INSIDE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS SMUDGED PRINT BETWEEN THE 0.25ML AND 4ML MARKING. SOME OF THE GRAD LINES WERE MISSING MORE THAN 50%, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. BATCH 8338914 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. INVESTIGATION CONCLUSION: 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 BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. RATIONALE: NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD 1ML SYRINGE LUER-LOK¿ TIP HAD INCOMPLETE SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH NO.: 8338914. IT WAS REPORTED THAT THE SEALED SYRINGE HAD INCOMPLETE SCALE MARKINGS ON ITS BARREL. PER SCAR 19-1421: ON 25NOV2019, DURING A REQUESTED EXAMINATION OF 120 RETAIN CARTONS OF EYLEA VIAL LABELED DRUG PRODUCT (LDP) BY WAREHOUSE AND LOGISTICS (WHL), ONE SYRINGE WAS FOUND TO HAVE INCOMPLETE MARKINGS ON ITS BARREL. THE CARTON CONTAINING THE SYRINGE WITH INCOMPLETE MARKINGS WILL REMAIN INTACT WITH THE OTHER 119 CARTONS IN A BIN. THE OUTER CARTON WAS MARKED WITH A DEFECT DESCRIPTION FOR EASY RETRIEVAL. THIS LOT OF EYLEA VIAL LDP WILL REMAIN STORED AT 2-8C UNTIL FUTURE DISPOSAL BY WHL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409252 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 8338914 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other