BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 12837038 · Received November 18, 2021

    Report

    Report Number
    1119779-2021-01850
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    October 22, 2021
    Report Date
    January 4, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1083799. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2026. DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1127514. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2026. DEVICE MANUFACTURE DATE: (B)(6) 2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-12-03. H6: INVESTIGATION SUMMARY: THREE PHOTOS AND TWENTY LOOSE 1ML LUER LOCK SYRINGES WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. ALL TWENTY SAMPLES WERE OBSERVED TO HAVE EXCESSIVE LUBRICANT PRESENT INSIDE THE SYRINGE BARREL, ON THE PLUNGER ROD, AND ON THE BARREL EXTERIOR. ONE SAMPLE WAS OBSERVED TO BE MISSING ITS STOPPER ENTIRELY. ONE SAMPLE WAS OBSERVED TO HAVE MISSING PRINT NEAR THE FIRST FIVE GRAD LINES WHICH APPEARED TO HAVE BEEN SCRAPED OFF. THE CONDITIONS OBSERVED WERE NON-CONFORMING PER PRODUCT SPECIFICATION. THERE IS A KNOWN SILICONE ISSUE FOR PRODUCTION BATCH #1127514. OF THE COMPLAINTS RECEIVED FOR THIS BATCH KNOWN POTENTIALLY IMPACTED BOXES ARE 97-184. THE BOX NUMBERS THAT THE CUSTOMER CURRENTLY HAS IN STOCK ARE REQUIRED TO DETERMINE IF THE SCOPE EXPANDS BEYOND THOSE JUST LISTED. POTENTIAL ROOT CAUSE FOR THE MISSING STOPPER AND MISSING PRINT DEFECTS ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME FOR THESE CONDITIONS. BATCHES #0059908, #1083799, #1127514 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS FOR THESE DEFECTS. POTENTIAL ROOT CAUSES FOR THE EXCESSIVE SILICONE DEFECT WERE DETERMINED TO BE THE FOLLOWING: 1. IMPROPER POSITIONING OF THE SILICONE GUN LEADING TO OVERSPRAY ON BARREL FLANGES AND THE MACHINE DIAL. 2. EXCESSIVE SILICONE PRESENCE DUE TO THE MISUSE OF THE SILICONE GUN PURGE FUNCTION. 3. INADEQUATE CAPTURE AND CONFLICTION IN INSPECTION PROCEDURES FOR SILICONE OUTSIDE OF THE FLUID PATH. 4. IMPROPER ADJUSTMENT REQUIREMENTS FOR SILICONE PURGE FUNCTION. THE FOLLOWING CORRECTIVE ACTIONS HAVE BEEN AND WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND OTHERS RECEIVED FOR THIS BATCH AROUND EXCESSIVE SILICONE. ADDITIONALLY, LOCAL EXCEPTIONS REPORTS WERE OPENED TO TRACK ACTIONS AROUND THIS COMPLAINT. 1. THE SILICONE GUN PINNED DOWN AT THE OPTIMAL LOCATION TO PREVENT SILICONE OVERSPRAY FROM OCCURRING. COMPLETED: 11/2021. 2. THE SILICONE PURGE FUNCTION WILL NO LONGER BE ACCESSIBLE TO ANY OPERATORS ON THE MACHINE. ELECTRONIC CONTROLS WILL BE PUT IN PLACE TO ONLY ALLOW AUTHORIZED ENGINEERS AND TECHNICIANS ACCESS TO THE PURGE FUNCTION. DUE: 03/31/2022. 3. THE PROGRAM WILL BE UPDATED TO NOT ALLOW THE MACHINE TO RUN WHILE THE SILICONE GUN IS PURGING. DUE: 03/31/2022. 4. UPDATE INSPECTION PROCEDURES AND INTERNAL GUIDEBOOKS TO ADEQUATELY CAPTURE THIS DEFECT. DUE: 03/31/2022. 5. ADJUSTMENT PROCEDURE FOR SILICONE GUN PURGE FUNCTION WILL BE UPDATED TO PROPERLY QUALIFY PRODUCT AND CLEAN IMPACTED MACHINE AREAS POST PURGE. DUE: 03/31/2022. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD LUER-LOK¿ SYRINGE FROM LOT 1083799 HAD VISIBLE, OILY LIQUID ABOVE THE PLUNGER, AND 1 SYRINGE FROM LOT 1127514 HAD LIGHT SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "SEVERAL SYRINGES WHICH ARE SLIPPERY/GREASY TO THE TOUCH AND ON WHICH THE LABEL DOES NOT STICK 1 SYRINGE WITH A DROP OF OILY LIQUID ABOVE THE PLUNGER 1 SYRINGE WITHOUT RUBBER, 1 SYRINGE WITH POOR PRINTING." "THE OIL DROP IS DIFFICULT TO SEE BECAUSE ALMOST THE ENTIRE TOP PART IS FILLED WITH OIL."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD LUER-LOK¿ SYRINGE FROM LOT 1083799 HAD VISIBLE, OILY LIQUID ABOVE THE PLUNGER, AND 1 SYRINGE FROM LOT 1127514 HAD LIGHT SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "SEVERAL SYRINGES WHICH ARE SLIPPERY/GREASY TO THE TOUCH AND ON WHICH THE LABEL DOES NOT STICK. 1 SYRINGE WITH A DROP OF OILY LIQUID ABOVE THE PLUNGER. 1 SYRINGE WITHOUT RUBBER, 1 SYRINGE WITH POOR PRINTING." "THE OIL DROP IS DIFFICULT TO SEE BECAUSE ALMOST THE ENTIRE TOP PART IS FILLED WITH OIL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738922 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown