BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 11585949 · Received March 29, 2021

    Report

    Report Number
    1213809-2021-00179
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 20, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: (B)(6) 2021. H6: INVESTIGATION SUMMARY TWO PHOTOS EACH DISPLAYING A SINGLE LOOSE 1ML SYRINGE WERE RECEIVED AND EVALUATED. ONE OF THE SYRINGES HAD A PORTION OF THE "SINGLE USE ONLY" MISSING AND ONE SYRINGE WAS NEARLY COMPLETELY BLANK. BOTH SYRINGES WERE REJECTABLE PER PRODUCT SPECIFICATION. ADDITIONALLY, ONE PHYSICAL 1ML SYRINGE WAS RECEIVED. THE SYRINGE APPEARED TO MATCH ONE OF THE SYRINGES SHOWN IN THE PHOTO AND WAS NEARLY COMPLETELY BLANK. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. MOST LIKELY A BUILDUP OF INK INHIBITED THE PROPER FLOW AND TRANSFER OF INK. THE MISSING INK DEFECT WAS FOUND DURING THE MANUFACTURE OF THIS BATCH, ADJUSTMENTS WERE MADE AND THE PRODUCT WAS RECALCIFIED. IT IS POSSIBLE A SMALL NUMBER OF SYRINGES WERE ABLE TO ESCAPE DETECTION. THE AQL FOR POOR PRINTING IS 0.25%. THE DEFECTIVE RATE IDENTIFIED IS 4 OUT OF 302,400, WHICH IS 0.0013%. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0002665 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 SYRINGE LUER-LOK¿ TIP HAD NO SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE COMPLAINANT REPORTED THAT THEY FOUND A 1ML DOSAGE SYRINGE WITHOUT ANY GRADUATION. CAUSE CODE: SYRINGE PRINTING (GRADUATION ABSENT)"

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TWO PHOTOS EACH DISPLAYING A SINGLE LOOSE 1ML SYRINGE WERE RECEIVED AND EVALUATED. ONE OF THE SYRINGES HAD A PORTION OF THE "SINGLE USE ONLY" MISSING AND ONE SYRINGE WAS NEARLY COMPLETELY BLANK. BOTH SYRINGES WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT MAY HAVE BEEN DUE TO A BUILD UP OF INK THAT PREVENTED THE PROPER FLOW AND TRANSFER OF INK. THE MISSING INK DEFECT WAS FOUND DURING THE MANUFACTURE OF THIS BATCH AND A REQUALIFICATION WAS PERFORMED. IT IS POSSIBLE A SMALL NUMBER OF SYRINGES WERE ABLE TO ESCAPE DETECTION. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0002665 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP HAD NO SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE COMPLAINANT REPORTED THAT THEY FOUND A 1ML DOSAGE SYRINGE WITHOUT ANY GRADUATION. CAUSE CODE: SYRINGE PRINTING (GRADUATION ABSENT)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481992 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 0002665 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1