BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 10225272 · Received July 2, 2020

    Report

    Report Number
    1213809-2020-00431
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    June 4, 2020
    Report Date
    August 11, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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: 7/10/2020. H.6. INVESTIGATION: TWENTY-ONE 10ML SYRINGES IN ZIPLOCK BAGS WERE RECEIVED AND EVALUATED. THREE BAGS WERE LABELED WITH BATCH 9150945. ONE BAG CONTAINED SIX SYRINGES IN AN OPENED CONVENIENCE TRAY WITH TOP WEB FROM BATCH 9150945 (P/N 309605). IT WAS OBSERVED THERE WAS A LONG BLACK HAIR IN THE BOTTOM OF TRAY LARGER THAN LEVEL 3 IN SIZE. ONE BAG CONTAINED A SINGLE LOOSE SYRINGE WITH A SMALL BLACK FOREIGN MATTER PARTICLE ATTACHED TO THE COLLAR. THE PARTICLE APPEARED TO BE INK AND WAS LARGER THAN LEVEL 3 IN SIZE. ONE BAG CONTAINED A SINGLE LOOSE SYRINGE WITH A STOPPER NOT FULLY SECURED TO THE END OF THE PLUNGER ROD. THE STOPPER WAS PARTIALLY JAMMED BETWEEN THE BARREL WALL AND A RIB OF THE PLUNGER ROD. TWO BAGS WERE LABELED WITH BATCH 9207816. EACH BAG CONTAINED A SINGLE LOOSE SYRINGE. ONE SYRINGE WAS OBSERVED TO HAVE SOME DAMAGE PRESENT ON THE COLLAR AND TIP OF THE SYRINGE WITH SMALL PIECES OF PLASTIC PROTRUDING OUTWARDS. ONE SYRINGE WAS OBSERVED TO A PORTION A PLUNGER ROD RIB, UNDER THE THUMB REST, ALMOST BROKEN OFF WITH A LARGE PIECE OF PLASTIC PROTRUDING OUTWARDS. ONE BAG WAS LABELED WITH BATCH 9092595 AND CONTAINED A SINGLE LOOSE SYRINGE. IT WAS OBSERVED THE SCALE PRINTED ON THE SYRINGE WAS SKEWED AND TWISTED 1/4 AROUND THE BARREL WITH A PORTION OF THE "BD" CUT OFF. ONE BAG WAS LABELED WITH BATCH 9092599 AND CONTAINED A SINGLE LOOSE SYRINGE. IT WAS OBSERVED THE SYRINGE HAD A JAMMED STOPPER CONDITION WITH THE STOPPER WEDGED BETWEEN THE BOTTOM OF THE PLUNGER ROD AND THE BARREL WALL. TWO BAGS WERE LABELED WITH BATCH 9150942. ONE BAG CONTAINED A SINGLE LOOSE SYRINGE WITH THE STOPPER NOT FULLY SECURED TO THE PLUNGER ROD AND WAS WEDGE BETWEEN THE PLUNGER ROD AND BARREL WALL. ONE BAG CONTAINED THREE LOOSE SYRINGES. TWO OF THE SYRINGES CONTAINED BLACK EMBEDDED FOREIGN MATTER PARTICLES PRESENT ON THROUGHOUT THE PLUNGER RODS. THE PARTICLES APPEARED TO BE BURNT PLASTIC WITH EACH HAVING AT LEAST ONE PARTICLE LARGER THAN LEVEL 3 IN SIZE. THE PLUNGER RODS WERE FROM MOLD C-197 CAVITY 45 AND 7. ONE SYRINGE CONTAINED BLACK EMBEDDED FOREIGN MATTER PARTICLES THROUGHOUT THE BARREL WITH A HIGH CONCENTRATION OF PARTICLES IN THE COLLAR. THE PARTICLES APPEARED TO BE BURNT PLASTIC WITH AT LEAST ONE PARTICLE LARGER THAN LEVEL 3 IN SIZE. THE BARREL WAS FROM MOLD C-246 CAVITY 18. FOUR BAGS WERE LABELED WITH MULTIPLE BATCH NUMBERS INDICATING THE TRACEABILITY WAS LOST AND THE ACTUAL BATCH NUMBERS ARE UNKNOWN. ONE BAG DID NOT HAVE ANY BATCH NUMBER LISTED. IN THE FIVE BAGS THERE WAS A TOTAL OF SIX SYRINGES. ONE SYRINGE HAD A SMALL AMOUNT OF DAMAGE PRESENT ON THE COLLAR WITH SOME PLASTIC PIECE PROTRUDING OUTWARDS. ONE SYRINGE HAD A LOOSE BLACK FOREIGN MATTER PARTICLE PRESENT OUTSIDE THE FLUID PATH. THE PARTICLE APPEARED TO BE A PORTION OF THE STOPPER AND WAS LARGER THAN LEVEL 3 IN SIZE. ONE SYRINGE HAD A SMALL BLACK PARTICLE ATTACHED TO THE TOP FLANGE NEAR THE OPENING OUTSIDE THE FLUID PATH. THERE WAS ALSO SOME MINOR DAMAGE PRESENT IN THE SAME LOCATION. THE PARTICLE APPEARED TO BE A PIECE OF PLASTIC AND WAS SMALLER THAN LEVEL 3 IN SIZE, WHICH WAS ACCEPTABLE PER PRODUCT SPECIFICATION. TWO SYRINGES HAD A JAMMED STOPPER CONDITION, WITH A PORTION OF THE STOPPER WEDGED BETWEEN THE BOTTOM OF THE PLUNGER ROD AND BARREL WALL. ONE SYRINGE HAD TWO CRACKED PLUNGER ROD RIBS. THE CRACKS WERE CRESCENT SHAPED AND WERE IN THE MIDDLE OF THE PLUNGER ROD. ALL THE SYRINGES WERE REJECTABLE PER APPLICABLE PRODUCT SPECIFICATION, UNLESS INDICATED OTHERWISE. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCHES 9092595, 9150942, 9150945, 9207816 AND 9207805 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BATCHES 9092599 AND 9150954 ARE NOT VALID. THE POTENTIAL ROOT CAUSE FOR THE DAMAGED COMPONENTS, PLASTIC FOREIGN MATTER, AND JAMMED/INSECURE STOPPER DEFECTS ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. THE POTENTIAL ROOT CAUSE FOR THE SKEWED SCALE AND INK FOREIGN MATTER DEFECTS ARE ASSOCIATED WITH THE MARKING PROCESS. THE POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE POTENTIAL ROOT CAUSE FOR HAIR FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. LASTLY, THE POTENTIAL ROOT CAUSE FOR STOPPER FOREIGN MATTER DEFECT IS ASSOCIATED WITH DEFECTIVE MATERIAL FROM THE SUPPLIER. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON ANY OF THE DEFECTIVE RATES IDENTIFIED. BATCHES 9092595, 9150942, 9150945, 9207816, AND 9207805 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGES WITH THE LUER-LOK¿ TIP HAD DAMAGE TO THEIR PLUNGERS/STOPPERS, WHILE OTHERS HAD PARTIALLY MISSING SCALE MARKINGS. THESE WERE FOUND PRIOR TO USE. LOT 9092595 HAD 1 OCCURRENCE OF SCALE ISSUES, LOT 9150942 HAD 3 OCCURRENCES OF FOREIGN MATTER, LOT 9150945 HAD 1 OCCURRENCE OF FOREIGN MATTER, AND 1 OCCURRENCE OF A DAMAGED PLUNGER ROD, LOT 9207816 HAD 1 OCCURRENCE OF A CRACKED BARREL AND 1 OCCURRENCE OF TIP BREAKAGE, AND LOT 9150945 HAD 1 OCCURRENCE OF FOREIGN MATTER. ADDITIONALLY, UNSPECIFIED LOTS HAD 3 OCCURRENCES OF BROKEN PLUNGER RODS, 1 OCCURRENCE OF A CRACKED BARREL, 2 DIFFERENT OCCURRENCES OF FOREIGN MATTER, AND 1 OCCURRENCE OF TIP BREAKAGE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE CONTINUING TO SEE BREAKDOWN OF THE PLUNGER AFTER THE SYRINGE AFTER MEDICATION IS PUT INTO THE SYRINGE. WE LOSE ABOUT 30+ SYRINGES PER BATCH OF ~1700 DUE TO THIS ISSUE. ONE OF THESE PICTURES ACTUALLY SHOWS EXTRA CLEAR PLASTIC ADHERED TO THE INSIDE OF THE PLUNGER."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9092595, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-04-02. MEDICAL DEVICE LOT #: 9150942, MEDICAL DEVICE EXPIRATION DATE: 2024-05-31, DEVICE MANUFACTURE DATE: 2019-05-30. MEDICAL DEVICE LOT #: 9150945, MEDICAL DEVICE EXPIRATION DATE: 2024-05-31, DEVICE MANUFACTURE DATE: 2019-05-30. MEDICAL DEVICE LOT #: 9207816, MEDICAL DEVICE EXPIRATION DATE: 2024-07-31, DEVICE MANUFACTURE DATE: 2019-07-26 . MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 SYRINGES WITH THE LUER-LOK¿ TIP HAD DAMAGE TO THEIR PLUNGERS/STOPPERS, WHILE OTHERS HAD PARTIALLY MISSING SCALE MARKINGS. THESE WERE FOUND PRIOR TO USE. LOT 9092595 HAD 1 OCCURRENCE OF SCALE ISSUES, LOT 9150942 HAD 3 OCCURRENCES OF FOREIGN MATTER, LOT 9150945 HAD 1 OCCURRENCE OF FOREIGN MATTER, AND 1 OCCURRENCE OF A DAMAGED PLUNGER ROD, LOT 9207816 HAD 1 OCCURRENCE OF A CRACKED BARREL AND 1 OCCURRENCE OF TIP BREAKAGE, AND LOT 9150945 HAD 1 OCCURRENCE OF FOREIGN MATTER. ADDITIONALLY, UNSPECIFIED LOTS HAD 3 OCCURRENCES OF BROKEN PLUNGER RODS, 1 OCCURRENCE OF A CRACKED BARREL, 2 DIFFERENT OCCURRENCES OF FOREIGN MATTER, AND 1 OCCURRENCE OF TIP BREAKAGE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE CONTINUING TO SEE BREAKDOWN OF THE PLUNGER AFTER THE SYRINGE AFTER MEDICATION IS PUT INTO THE SYRINGE. WE LOSE ABOUT 30+ SYRINGES PER BATCH OF ~1700 DUE TO THIS ISSUE. ONE OF THESE PICTURES ACTUALLY SHOWS EXTRA CLEAR PLASTIC ADHERED TO THE INSIDE OF THE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686488 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309605 SEE SECTION H.10. 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other