BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 18401329 · Received December 27, 2023

    Report

    Report Number
    1911916-2023-00919
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    December 13, 2023
    Report Date
    January 5, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903010313
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE WERE THREADS ON THE RIBS OF THE PLUNGER, INK DOTS, A BROKEN PLUNGER, VISIBLE SILICONE AND A STOPPER NOT PROPERLY SEATED IN THE SYRINGE. TO AID IN THE INVESTIGATION, EIGHTY-NINE SAMPLES IN PLASTIC BAGS AND FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE HAS A HANDWRITTEN NOTE THAT STATES, 'LOT 2032060 STOPPER.' A VISUAL INSPECTION WAS PERFORMED WITH 10X MAGNIFICATION. SIX SAMPLES HAVE A SPECK OF EMBEDDED DEGRADED RESIN. ONE SAMPLE HAS SYRINGE WITH PLUNGER ROD RIB DAMAGE. SEVENTY-SIX SAMPLES HAVE A PLASTIC FLASH AT THE PLUNGER ROD; THIS IS CONSIDERED AN ACCEPTABLE IMPERFECTION. THE SAMPLE FROM LOT 2032060, AND THE REMAINING SAMPLES RECEIVED, HAVE NO DEFECTS OR IMPERFECTIONS. THE FOUR PHOTOS PROVIDED SHOW A SYRINGE PLUNGER ROD WITH A PLASTIC FLASH. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PLASTIC FLASH CAN OCCUR IF THERE IS A TEMPERATURE VARIATION DURING THE MOLDING PROCESS. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. FOR THE DAMAGED PLUNGER ROD, IT IS LIKELY THAT A JAM OCCURRED DURING THE ASSEMBLY PROCESS RESULTING IN THE DAMAGE TO THE SYRINGES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031, LOTS 2242057 AND 2032060. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. HERE IS A NEW NOTIFICATION ON THE 20ML SYRINGES. ALSO IN THIS BATCH WE COME ACROSS THE SYRINGES WITH LOOSE PARTICLES/THREADS ON THE RIBS OF THE PLUNGER. THIS IS THE SAME REPORT AS WITH #8979134 AND PLEASE INCLUDE FINDINGS OF THESE REPORTS IN THE CONCLUSIONS. THIS IS THE 3RDBATCH WHERE WE ENCOUNTER THIS ANOMALY. SOME SYRINGES SHOW WORSE THAN OTHERS, BUT THERE SEEMS TO BE A STRUCTURAL PROBLEM HERE IN THE PRODUCTION OF THESE PLUNGERS. SEE ATTACHED PHOTOS FOR CONFIRMATION OF THE DEVIATION. THERE IS A RISK OF THOSE PARTICLES COMING OFF AND LOOSE PARTICLES ARE NOT ACCEPTABLE WHEN USING THE SYRINGES. WE PROCESSED THE ENTIRE BATCH OF 26 BOXES OF 375 PIECES AND CARRIED OUT A 100% CHECK BECAUSE OF THIS DEVIATION. ITEM NUMBER: 301031. BATCH: 2242057. WE FOUND THE FOLLOWING ANOMALIES DURING PACKAGING, I.E. BEFORE USE: 75 X SYRINGE WITH PARTICLE/THREAD (SEE PHOTOS). THIS IS THE BIGGEST ISSUE FOR WHICH WE WOULD LIKE TO SEE ANSWERS AND MEASURES AS SOON AS POSSIBLE. FOR THE SAKE OF COMPLETENESS, THE FOLLOWING ANOMALIES WERE ALSO FOUND: 6 X SYRINGE WITH INK DOTS. 1 X SYRINGE WITH BROKEN PLUNGER. 3 X SYRINGE WITH VISIBLE SILICONE. (I HEREBY ALSO REPORT 1 DEVIATION ON BATCH 2032060, ARTICLE 301031. THE STOPPER WAS NOT PROPERLY SEATED IN THE SYRINGE. A CUSTOMER REPORTED THIS TO US AND WE ARE THEREFORE STILL SUBMITTING IT. THIS SYRINGE IS ALSO AVAILABLE FOR COLLECTION AND I CAN INCLUDE IT IN THE BOX OF THIS COLLECTION). THE SAMPLES ARE AVAILABLE FOR COLLECTION FOR EXAMINATION.

    Description of Event or Problem · 0

    HERE IS A NEW NOTIFICATION ON THE 20ML SYRINGES. ALSO IN THIS BATCH WE COME ACROSS THE SYRINGES WITH LOOSE PARTICLES/THREADS ON THE RIBS OF THE PLUNGER. THIS IS THE SAME REPORT AS WITH #8979134 AND PLEASE INCLUDE FINDINGS OF THESE REPORTS IN THE CONCLUSIONS. THIS IS THE 3RDBATCH WHERE WE ENCOUNTER THIS ANOMALY. SOME SYRINGES SHOW WORSE THAN OTHERS, BUT THERE SEEMS TO BE A STRUCTURAL PROBLEM HERE IN THE PRODUCTION OF THESE PLUNGERS. SEE ATTACHED PHOTOS FOR CONFIRMATION OF THE DEVIATION. THERE IS A RISK OF THOSE PARTICLES COMING OFF AND LOOSE PARTICLES ARE NOT ACCEPTABLE WHEN USING THE SYRINGES. WE PROCESSED THE ENTIRE BATCH OF 26 BOXES OF 375 PIECES AND CARRIED OUT A 100% CHECK BECAUSE OF THIS DEVIATION. ITEM NUMBER: 301031. BATCH: 2242057. WE FOUND THE FOLLOWING ANOMALIES DURING PACKAGING, I.E. BEFORE USE: 75 X SYRINGE WITH PARTICLE/THREAD (SEE PHOTOS). THIS IS THE BIGGEST ISSUE FOR WHICH WE WOULD LIKE TO SEE ANSWERS AND MEASURES AS SOON AS POSSIBLE. FOR THE SAKE OF COMPLETENESS, THE FOLLOWING ANOMALIES WERE ALSO FOUND: 6 X SYRINGE WITH INK DOTS. 1 X SYRINGE WITH BROKEN PLUNGER. 3 X SYRINGE WITH VISIBLE SILICONE. (I HEREBY ALSO REPORT 1 DEVIATION ON BATCH 2032060, ARTICLE 301031. THE STOPPER WAS NOT PROPERLY SEATED IN THE SYRINGE. A CUSTOMER REPORTED THIS TO US AND WE ARE THEREFORE STILL SUBMITTING IT. THIS SYRINGE IS ALSO AVAILABLE FOR COLLECTION AND I CAN INCLUDE IT IN THE BOX OF THIS COLLECTION). THE SAMPLES ARE AVAILABLE FOR COLLECTION FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110940 SYRINGE 20ML LL BNS SYRINGE, PISTON JKA BECTON DICKINSON 2242057 50382903010313
    2265222 SYRINGE 20ML LL BNS SYRINGE, PISTON JKA BECTON DICKINSON 2242057 50382903010313

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown