BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 8080148 · Received November 16, 2018

    Report

    Report Number
    1911916-2018-00656
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    November 1, 2018
    Report Date
    January 17, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER, DAMAGED SYRINGES, SCALE MARKING ERRORS AND INCLUSIONS OF FOREIGN MATTER ACROSS SEVEN DIFFERENT LOTS. FOR LOT 7170596 THERE WERE 12 OCCURRENCES OF FOREIGN MATTER, 4 OCCURRENCES OF DAMAGED SYRINGES, 13 OCCURRENCES OF SCALE MARKING ERRORS. FOR LOT 7206511 THERE WERE 39 OCCURRENCES OF FOREIGN MATTER, 56 OCCURRENCES OF DAMAGED SYRINGES, 160 OCCURRENCES OF SCALE MARKING ERRORS, AND 18 OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. FOR LOT 7206950 THERE WERE 18 OCCURRENCES OF DAMAGED SYRINGES, 37 OCCURRENCES OF SCALE MARKING ERRORS, AND 21 OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. FOR LOT 7206973 THERE WERE 51 OCCURRENCES OF FOREIGN MATTER, 33 OCCURRENCES OF DAMAGED SYRINGES, 148 OCCURRENCES OF SCALE MARKING ERRORS. AND 36 OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. FOR LOT 7206974 THERE WERE 33 OCCURRENCES OF FOREIGN MATTER, 91 OCCURRENCES OF DAMAGED SYRINGES, 154 OCCURRENCES OF SCALE MARKING ERRORS AND 15 OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. FOR LOT 7206988 THERE WERE 71 OCCURRENCES OF FOREIGN MATTER, 81 OCCURRENCES OF DAMAGED SYRINGES, 373 OCCURRENCES OF SCALE MARKING ERRORS AND 46 OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. FOR LOT 7206990 THERE WERE 31 OCCURRENCES OF FOREIGN MATTER, 78 OCCURRENCES OF DAMAGED SYRINGES AND 17 OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. DHR REVIEWS FOR ALL LOTS ARE AS FOLLOWS. 7170596: 6 PACKAGE INSPECTIONS, 6 PRINT/ASSEMBLY INSPECTIONS, NO FAILURES RECORDED. NO DEFECTS OR QNS RECORDED. 860#2. 7206511: 6 PACKAGE INSPECTIONS, 7 PRINT/ASSEMBLY INSPECTIONS, NO FAILURES RECORDED. NO DEFECTS OR QNS RECORDED. PRINTER WAS DOWN FOR 2 HOURS AND REPLACED INK HOSES, NO PRODUCT WAS AFFECTED. 860#2. 7206950: 14 PACKAGE INSPECTIONS, 5 PRINT/ASSEMBLY INSPECTIONS*, NO FAILURES RECORDED. * HALF OF THE BATCH WAS OVERFLOW FROM BLISTERPAK BATCHES 7153905, 7153900. NO DEFECTS OR QNS RECORDED. 860#2. 7206973: 11 PACKAGE INSPECTIONS, 7 PRINT/ASSEMBLY INSPECTIONS*, NO FAILURES RECORDED. * HALF OF THE BATCH WAS OVERFLOW FROM BLISTERPAK BATCHES 7180575, 7180634. NO DEFECTS OR QNS RECORDED. 860 #1 AND #2. 7206974: 13 PACKAGE INSPECTIONS, 6 PRINT/ASSEMBLY INSPECTIONS*, ONE FAILURE RECORDED. MISSING PRINT REJECTION (860 #1). ROOT CAUSE- CAUSED BY SHIM UNDER THE DELRON GUIDE ON THE PRINTER. CORRECTIVE ACTION- REMOVED SHIM AND TIGHTENED GUIDE. TOTAL REJECTED: 8500. STAT SAMPLED USING AQL .25%. REFERENCE QN (B)(4). * HALF OF THE BATCH WAS OVERFLOW FROM BLISTERPAK BATCHES 7180636, 7180621. 860 #1 AND #2. 7206988: 17 PACKAGE INSPECTIONS, NO FAILURES RECORDED. BATCH WAS OVERFLOW BULK FROM BLISTERPAK BATCHES 7180641, 7180664, 7180662, 7180661, 7215900, 7215905. NO DEFECTS OR QNS RECORDED. 860 #1 AND #2. 7206990: 8 PACKAGE INSPECTIONS, 7 PRINT/ASSEMBLY INSPECTIONS, NO FAILURES RECORDED. NO DEFECTS OR QNS RECORDED. 860 #2. 7227658: 6 PACKAGE INSPECTIONS, 5 PRINT/ASSEMBLY INSPECTIONS, NO FAILURES RECORDED. NO DEFECTS OR QNS RECORDED. 860 #2. 7227660: 7 PACKAGE INSPECTIONS, 8 PRINT/ASSEMBLY INSPECTIONS, NO FAILURES RECORDED. NO DEFECTS OR QNS RECORDED. 860 #2. 7227663: 9 PACKAGE INSPECTIONS, 9 PRINT/ASSEMBLY INSPECTIONS, NO FAILURES RECORDED. NO DEFECTS OR QNS RECORDED. 860 #2. 7227664: 7 PACKAGE INSPECTIONS, 7 PRINT/ASSEMBLY INSPECTIONS, NO FAILURES RECORDED. NO DEFECTS OR QNS RECORDED. 860 #2. 7227702: 8 PACKAGE INSPECTIONS, 8 PRINT/ASSEMBLY INSPECTIONS, NO FAILURES RECORDED. NO DEFECTS OR QNS RECORDED. 860 #2. 7227712: 7 PACKAGE INSPECTIONS, 4 PRINT/ASSEMBLY INSPECTIONS, NO FAILURES RECORDED. THERE WAS SOME DOWNTIME ON THE ASSEMBLY MACHINE NOTED, HOWEVER NOTHING WAS RECORDED IF THE ISSUE HAD A QUALITY IMPACT (LIKELY IT DIDN¿T, BUT MENTIONING THAT IT WASN¿T SPECIFICALLY CALLED OUT). NO DEFECTS OR QNS RECORDED. 860 #2. INVESTIGATION CONCLUSION: BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: 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

    B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER, DAMAGED SYRINGES, SCALE MARKING ERRORS AND INCLUSIONS OF FOREIGN MATTER ACROSS SEVEN DIFFERENT LOTS. FOR LOT 7170596 THERE WERE 12 OCCURRENCES OF FOREIGN MATTER, 4 OCCURRENCES OF DAMAGED SYRINGES, 13 OCCURRENCES OF SCALE MARKING ERRORS. FOR LOT 7206511 THERE WERE 39 OCCURRENCES OF FOREIGN MATTER, 56 OCCURRENCES OF DAMAGED SYRINGES, 160 OCCURRENCES OF SCALE MARKING ERRORS, AND 18 OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. FOR LOT 7206950 THERE WERE 18 OCCURRENCES OF DAMAGED SYRINGES, 37 OCCURRENCES OF SCALE MARKING ERRORS, AND 21OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. FOR LOT 7206973 THERE WERE 51 OCCURRENCES OF FOREIGN MATTER, 33 OCCURRENCES OF DAMAGED SYRINGES, 148 OCCURRENCES OF SCALE MARKING ERRORS. AND 36 OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. FOR LOT 7206974 THERE WERE 33 OCCURRENCES OF FOREIGN MATTER, 91 OCCURRENCES OF DAMAGED SYRINGES, 154 OCCURRENCES OF SCALE MARKING ERRORS AND 15 OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. FOR LOT 7206988 THERE WERE 71 OCCURRENCES OF FOREIGN MATTER, 81 OCCURRENCES OF DAMAGED SYRINGES, 373 OCCURRENCES OF SCALE MARKING ERRORS AND 46 OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. FOR LOT 7206990 THERE WERE 31 OCCURRENCES OF FOREIGN MATTER, 78 OCCURRENCES OF DAMAGED SYRINGES AND 17OCCURRENCES OF INCLUSIONS OF FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 #: 7170596, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2017-06-19. MEDICAL DEVICE LOT #: 7206511, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-07-25. MEDICAL DEVICE LOT #: 7206950, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-07-25. MEDICAL DEVICE LOT #: 7206973, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-07-25. MEDICAL DEVICE LOT #: 7206974, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-07-25. MEDICAL DEVICE LOT #: 7206988, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-07-25. MEDICAL DEVICE LOT #: 7206990, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2017-07-25. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD LUER-LOK¿ SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER, DAMAGED SYRINGES AND SCALE MARKING ERRORS. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921445 BD LUER-LOK¿ SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other