BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL BNS

    MDR report key: 21852167 · Received April 16, 2025

    Report

    Report Number
    1213809-2025-00282
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 20, 2025
    Report Date
    June 30, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903096485
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). SUPPLEMENTAL MDR - SILICONE VISIBLE. ONE HUNDRED AND EIGHTY-ONE SYRINGES FROM BATCH 4123603 WERE RECEIVED AND EVALUATED. ALL SAMPLES WERE RECEIVED LOOSE IN TEN SMALLER BAGS. NO EXCESSIVE SILICONE WAS OBSERVED, AND THOSE SAMPLES WERE DEEMED ACCEPTABLE. HOWEVER, MULTIPLE NON-CONFORMANCES WERE IDENTIFIED: FIFTY-ONE SYRINGES WERE MISSING PLUNGERS AND STOPPERS, FORTY-FIVE SYRINGES HAD BENT PLUNGER RODS, TWENTY-EIGHT SYRINGES SHOWED BROWNISH DISCOLORATION CONSISTENT WITH EMBEDDED FOREIGN MATTER, AND THREE SYRINGES HAD AIR BUBBLES. ADDITIONALLY, NINE SYRINGES HAD SCUFFED BARRELS CAUSING A HAZY APPEARANCE, AND ONE HAD TWO STOPPERS INSIDE THE BARREL. PRINTING DEFECTS WERE ALSO NOTED, INCLUDING TWENTY-TWO SYRINGES WITH MISSING SCALE MARKINGS, TWELVE SYRINGES WITH SMEARED PRINT, TWELVE SYRINGES WITH MISALIGNED ZERO LINES, AND TWO WITH DOUBLE PRINT. THESE CONDITIONS ARE NON-CONFORMING PER PRODUCT SPECIFICATIONS. THE EMBEDDED FOREIGN MATTER AND AIR BUBBLE DEFECTS ARE LIKELY RELATED TO THE MOLDING PROCESS. THE EMBEDDED MATERIAL IS MOST LIKELY DEGRADED PLASTIC, WHICH CAN OCCUR WHEN RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START-UP. THIS IS CONSIDERED A COSMETIC DEFECT AND DOES NOT POSE A RISK TO THE CUSTOMER. AIR BUBBLES MAY RESULT FROM WATER PARTICLES ENTERING THE MOLD, VAPORIZING, AND BECOMING TRAPPED IN THE PART. SCALE MARKING DEFECTS ARE ASSOCIATED WITH THE MARKING PROCESS. DEFECTS SUCH AS MISSING OR DAMAGED PLUNGERS, DAMAGED BARRELS, AND MISSING STOPPERS ARE LINKED TO THE ASSEMBLY PROCESS. A NOTIFICATION WAS ISSUED DURING PRODUCTION FOR THE SMEARED PRINT AND STOPPER DEFECTS, AND A REQUALIFICATION WAS PERFORMED TO CLEAR THE LINE. HOWEVER, A LIMITED NUMBER OF DEFECTIVE UNITS MAY HAVE ESCAPED DETECTION. 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 · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL BNS HAD SILICONE VISIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HEREBY SUBMIT OUR FINDINGS AT THE END OF BATCH, AS AGREED UPON. ALL DEVIATIONS WERE FOUND DURING PACKAGING, PRIOR TO STERILIZATION. SO PRIOR TO USE, SO NO MEDICATION AND NO PATIENTS ARE INVOLVED. ARTICLE CODE: 309648, 1ML BULK NS LL. BATCHES: 4123603. EVENT DATE: 20/03/2025. STAXS COMPLAINT REF: (B)(4). DEVIATIONS: FIRST, I WOULD LIKE TO NOTIFY YOU THAT WE SEE AN OVERALL DECLINE IN QUALITY. THE TOTAL NUMBER OF DEVIATIONS IS INCREASING BUT ALSO THE TYPE OF DEVIATIONS IS WORRYING. THEY ARE TOO OBVIOUS. SCALE MARKING ISSUES WERE MINOR IN THE PAST, NOW MANY DO NOT LOOK GOOD AT ALL. IN THE PAST WE HAD A REJECT RATE OF (B)(4) AND NOW IT¿S LIKE (B)(4), A TENFOLD. 40 X VISIBLE SILICON OIL, 45 X CROOKED PLUNGER, 45 X BROWN STAINS, 51 X MISSING PLUNGER (JUST THE PISTON). 39 X HAZY PISTON, 1 X DOUBLE STOPPER IN PISTON, 6 X EMBEDDED AIR BUBBLE. 850 X SYRINGES WITH SCALE MARKING ISSUES À DOUBLE SCALES, MISSING SCALES, MISSING NUMBERS, MISSING LINES, AND LOT OF CROOKED SCALES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121715 BD SYRINGE 1ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4123603 50382903096485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown