BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 10320504 · Received July 24, 2020

    Report

    Report Number
    1213809-2020-00487
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    May 11, 2020
    Report Date
    July 21, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: ONE PHOTO AND FOUR LOOSE 10ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED TWO OF THE SYRINGES WERE MISSING MOST OF THE SCALE WITH ONE SYRINGE HAVING MINOR DAMAGE AND ONE SYRINGE HAVING A SIGNIFICANT INDENTATION NEAR THE TIP. THE MISSING PRINT ON BOTH SYRINGES WERE REJECTABLE PER PRODUCT SPECIFICATION. ONE OF THE SYRINGES HAD THE STOPPER JAMMED BETWEEN THE BOTTOM OF THE PLUNGER ROD AND THE BARREL WALL, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. ONE OF THE SYRINGES WAS AN AMBER ORAL SYRINGE WITH THE CORRECT ENTERAL/ORAL PRINT, WHICH WAS NOT CONSISTENT WITH THE PRODUCT INFORMATION PROVIDED. IT WAS ALSO DISPLAYED IN THE PHOTO, THIS SYRINGE WAS AT THE TOP OF A BAG CONTAINING 10ML LL SYRINGES. THE MIXED PRODUCT DEFECT WAS REJECTABLE PER PRODUCT SPECIFICATION. DEVICE HISTORY REVIEWS WERE DONE ON THE POSSIBLE LOTS INVOLVED (0043667 AND 0002923). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCHES 0043667 AD 0002923 WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ASSEMBLY BATCHES WERE ALSO REVIEWED WITH NO AMBER ORAL BATCHES PRODUCED AT LEAST SEVEN DAYS BEFORE OR IMMEDIATELY AFTER. IT WAS FOUND THAT ONE 10ML AMBER ORAL BATCH WAS MANUFACTURED DURING THE TIME OF MANUFACTURE OF EITHER OF THE REPORTED 10ML LUER LOK BATCHES. THIS ORAL BATCH WAS MANUFACTURED ON A DIFFERENT MANUFACTURING LINE WHICH IS LOCATED ON THE OPPOSITE SIDE OF THE PLANT. THERE ARE MULTIPLE WALLS, DOORS, AND HALLWAYS BETWEEN THIS 10ML ORAL MACHINE AND THE 10ML HIGH VOLUME AREA WHERE THE COMPLAINT BATCHES WERE PRODUCED. NO ORAL PRODUCT WAS BROUGHT OVER TO THE LOCATION OF THE 10ML HIGH-VOLUME AREA WHERE THE COMPLAINT BATCHES WERE PRODUCED. ALL COMPLAINT BATCHES WERE MANUFACTURED IN LINE FROM PRINTING TO ASSEMBLY TO PACKAGING. NONE OF THE ADJACENT 10ML LINES IN THE HIGH-VOLUME AREA WERE PRODUCING AMBER SYRINGES DURING THAT TIME. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE SAMPLES AND PHOTOS PROVIDED. ROOT CAUSE DESCRIPTION: A POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT IS LIKELY THE MISSING PRINT WAS CAUSED BY A JAM AT THE PRINTER CAUSING THE BARRELS TO FEED INCORRECTLY. LASTLY, A POTENTIAL ROOT CAUSE FOR THE MIXED PRODUCT DEFECT IS POSSIBLY FROM PERSONNEL NOT FOLLOWING PROCEDURE. NO MIXED PRODUCT WAS OBSERVED DURING HOURLY INSPECTIONS. IT WAS NOT A RESULT OF NORMAL MATERIAL HANDLING PROCESSES AS THE MIXED ORAL SYRINGE WAS NEVER IN THE SAME REMOTE LOCATION AS THE 10ML LL PRODUCT. THE AQL FOR INCORRECT ASSEMBLY IS (B)(4). THE DEFECTIVE RATE IDENTIFIED IS 1 OUT OF 428,400, WHICH IS (B)(4). THE AQL FOR MISSING PRINT IS (B)(4). THE DEFECTIVE RATE IDENTIFIED IS 2 OUT OF 428,400, WHICH IS (B)(4). NO CORRECTIVE ACTIONS ARE NECESSARY FOR JAMMED STOPPER OR MISSING PRINT BASED ON THE DEFECTIVE RATES IDENTIFIED. BATCHES 0043667 AND 0002923 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS FOR THE DEFECTS LISTED ABOVE. BASED ON THE INFORMATION AVAILABLE TODAY AND THE INVESTIGATION PERFORMED, THE MIXED PRODUCT DEFECT IS CONSIDERED TO BE AN ISOLATED INSTANCE WITH LIMITED SCOPE OF ONE OR FEW PIECES. NO EVIDENCE WAS FOUND TO INDICATE A LARGER DEFECTIVE RATE THAN IDENTIFIED. RATIONALE: A PLANT WIDE COMMUNICATION WILL BE SENT OUT FOR AWARENESS OF THE MIXED PRODUCT DEFECT AS OF (B)(6) 2020. BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INVESTIGATING THE CUSTOMER'S BD SYRINGES WITH THE LUER-LOK¿ TIP FOR DISCOLORATION, 1 SYRINGE WAS FOUND WITH THE STOPPER JAMMED BETWEEN THE PLUNGER AND BARREL WALL, AND 1 SYRINGE HAD MISSING SCALE MARKINGS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING FOLLOW UP EMAIL CUSTOMER STATED THAT THE DISCOLORED SYRINGE CAME FROM MATERIAL NO. 301029. "IT WAS OBSERVED TWO OF THE SYRINGES WERE MISSING MOST OF THE SCALE WITH ONE SYRINGE HAVING MINOR DAMAGE AND ONE SYRINGE HAVING A SIGNIFICANT INDENTATION NEAR THE TIP. THE MISSING PRINT ON BOTH SYRINGES WERE REJECTABLE PER PRODUCT SPECIFICATION. ONE OF THE SYRINGES HAD THE STOPPER JAMMED BETWEEN THE BOTTOM OF THE PLUNGER ROD AND THE BARREL WALL, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783380 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other