BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP

    MDR report key: 10891207 · Received November 24, 2020

    Report

    Report Number
    1920898-2020-01612
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    November 12, 2020
    Report Date
    December 4, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 1CC SYRINGES WITH PART OF THE SHELF CARTON FROM LOT # 8162853. THIS ISSUE WAS FIRST OBSERVED DURING INVESTIGATION OF INVESTIGATION CHILD RECORD 1951126. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH EXHIBITED A DEFORMED STOPPER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8162853. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200769369, 200768465, 200768576,] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200768467] NOTED FOR SMEARED STOPPERS. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 1ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, AND CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL-CLEANING DIAL, LUBRICATION DIAL, ONE PLUNGER/STOPPER ASSEMBLY DIAL AND ONE SYRINGE ASSEMBLY DIAL AND VARIOUS INSPECTION AND TRANSFER DIALS. QUALITY NOTIFICATION # 200767467 WAS CREATED FOR SMEARED STOPPERS WHILE THIS PRODUCT WAS BEING PRODUCED. IT WAS FOUND THAT THE STOPPER SEATING BAR WAS SET TOO HIGH. THE ISSUE WAS RESOLVED BY ADJUSTING THE BAR TO THE CORRECT LOCATION AND TIGHTENING IT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP EXPERIENCED STOPPER DEFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE SHIELD, THE CUSTOMER FOUND THAT THE NEEDLE TIP WAS BENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DATE RECEIVED BY MANUFACTURER: THIS COMPLAINT WAS FIRST RECEIVED ON 10/23/2020 AND WAS ORIGINALLY CONSIDERED NON-REPORTABLE. ON 11/12/2020 SAMPLES WERE RECEIVED AS PART OF THE INVESTIGATION WHERE AN ADDITIONAL PRODUCT DEFECT WAS NOTED, CHANGING THE INCIDENT TO REPORTABLE. (B)(4). INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE HENCE THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE BENT ON LOT # 8162853 A REVIEW OF RISK MANAGEMENT (B)(4) REVISION 14 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, NEEDLE BENT) WAS CAPTURED AND ADDRESSED INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 1CC, 8MM SYRINGES WITH PART OF THE SHELF CARTON FROM LOT # 8162853. CUSTOMER STATES THAT WHEN REMOVING THE SHIELD, THE CUSTOMER FOUND THAT THE NEEDLE TIP WAS BENT. BOTH RETURNED SYRINGES WERE EXAMINED AND NO BENT CANNULA WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8162853. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP EXPERIENCED STOPPER DEFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE SHIELD, THE CUSTOMER FOUND THAT THE NEEDLE TIP WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354921 SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 8162853

    Patients

    Seq Age Sex Outcome Treatment
    1