BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALCOHOL SWABS

    MDR report key: 10009843 · Received April 29, 2020

    Report

    Report Number
    1920898-2020-00439
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    March 6, 2020
    Report Date
    June 11, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    LKB
    UDI-DI
    00382903268955
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 2020-05-13. H.3. DEVICE RETURNED TO MANUFACTURER: YES. H.3. DEVICE EVAL BY MANUFACTURER: YES. H.6. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER ON SWAB ON LOT # 9220975. INVESTIGATION SUMMARY: CUSTOMER RETURNED (9) BD ALCOHOL SWAB FROM LOT # 9220975 (3 OPEN, 6 SEALED). CUSTOMER STATES THAT THE SWABS HAVE A YELLOW TINT ON THE SIDES. THE RETURNED SWABS WERE EXAMINED AND ALL OPEN SAMPLES EXHIBITED A YELLOWISH DISCOLORATION OF THE SWAB PAD THAT APPEARS TO BE ABSORBED INTO THE SWAB PAD MATERIAL. NONE OF THE SEALED SWABS EXHIBITED A DISCOLORATION OF THE SWAB PAD MATERIAL. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9220975. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS 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 DESCRIPTION: AS PER INVESTIGATION COMPLETED BY MANUFACTURING UNDER INVESTIGATION CHILD 1611273, "ON (B)(6) 2020, HOLDREGE RECEIVED A PHOTO OF FM ON THE PAD FROM A BD ALCOHOL SWAB FROM BATCH 9220975 MATERIAL 326895. A VISUAL EVALUATION OF THE SWABS FOUND A LIGHT YELLOW ¿STAIN¿ ON ONE HALF OF THE PAD. THE SWABS WERE PRODUCED ON (B)(6) 2019 ¿ (B)(6) 2019 ON THE PRODO PAK OPERATION. PROCESS: AT THE SWAB MACHINES, WHEN A NEW ROLL OF MATERIAL (PAD AND OR FOIL) IS INTRODUCED, THE MATERIAL IS SPLICED TOGETHER WITH TAPE TO THE PREVIOUS ROLL TO AIDE IN CYCLING THE MATERIAL THROUGH THE MACHINE. THE TAPE IS MANUALLY APPLIED, BY THE SWAB ASSOCIATE, ONTO THE END OF THE ROLL THAT IS ON THE MACHINE AND ONTO THE NEW ROLL THAT IS BEING INTRODUCED. AN EYE (SICK EYE) ON EACH SIDE OF THE PAD ROLL (LANE 1 & LANE 10) IS USED TO DETECT THE TAPED SPLICE. WHEN THE EYE DETECTS THE SLICE, IT COUNTS (SO MANY CYCLES) AND AUTOMATICALLY REJECTS THE SWABS, PRIOR TO THE CARTON AN ACCUMULATOR INTO A WASTE BIN. INVESTIGATION: THE DHR, L2L DISPATCHES, LOGBOOKS AND QUALITY NOTIFICATIONS WERE ALL REVIEWED. NOTHING WAS FOUND PERTAINING TO THIS TYPE OF COMPLAINT. ROOT CAUSE: THIS IS THE 1ST RELATED COMPLAINT FOR DISCOLORED ON LOT #9220975. WITHOUT THE SAMPLE TO TEST WHAT THE STAIN ON THE POUCH MAY BE, ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITH BD¿ ALCOHOL SWABS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED THAT THERE IS A YELLOW TINT ON THE SIDES OF THE ALCOHOL SWABS."

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9220975. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITH BD¿ ALCOHOL SWABS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED THAT THERE IS A YELLOW TINT ON THE SIDES OF THE ALCOHOL SWABS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476134 BD ALCOHOL SWABS ALCOHOL SWAB LKB BD MEDICAL - DIABETES CARE 9220975 00382903268955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other