BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML 29G 12.7MM 10BAG 500 EU

    MDR report key: 10347987 · Received July 30, 2020

    Report

    Report Number
    1920898-2020-00968
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 23, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: LEVEL B 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 (BLOOD IN BARREL) ON LOT # 9182218. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, FOREIGN MATTER (BLOOD IN BARREL) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1CC, 12.7MM SYRINGE. CUSTOMER STATES THAT THEY HAD FOUND WHAT MAY HAVE BEEN BLOOD IN THEIR SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED REDDISH MATERIAL IN THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY BLOOD MIXED WITH SILICONE. THE BLOOD WOULD NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS. LEVEL A EVENT NO DHR OR QN REVIEW IS REQUIRED. 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. THE BLOOD WOULD NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML 29G 12.7MM 10BAG 500 EU HAD FOREIGN MATTER INSIDE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A SECOND EMAIL RECEIVED THIS MORNING TO FOLLOW SO THIS IS AN FYI. I WAS INFORMED THAT THE CUSTOMER THOUGHT THEY HAD FOUND WHAT MAY HAVE BEEN BLOOD IN THEIR SYRINGE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: LEVEL B 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 (BLOOD IN BARREL) ON LOT # 9182218. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, FOREIGN MATTER (BLOOD IN BARREL) WAS CAPTURED AND ADDRESSED INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A 1CC SYRINGE AND A SHELF CARTON FROM LOT # 9182218. CUSTOMER STATES THAT THEY HAD FOUND WHAT MAY HAVE BEEN BLOOD IN THEIR SYRINGE. THE PHOTOS WERE EXAMINED AND EXHIBITED A REDDISH MATERIAL INSIDE THE BARREL. IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM THE PHOTOS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9182218. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200833233] NOTED THAT DID NOT PERTAIN 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS IT IS DIFFICULT TO DETERMINE THE IDENTITY OF THIS MATERIAL SOLELY FROM THE PHOTOS. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1ML 29G 12.7MM 10BAG 500 EU HAD FOREIGN MATTER INSIDE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A SECOND EMAIL RECEIVED THIS MORNING TO FOLLOW SO THIS IS AN FYI. I WAS INFORMED THAT THE CUSTOMER THOUGHT THEY HAD FOUND WHAT MAY HAVE BEEN BLOOD IN THEIR SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808518 SYRINGE 1ML 29G 12.7MM 10BAG 500 EU SYRINGE FMF BD MEDICAL - DIABETES CARE 9182218

    Patients

    Seq Age Sex Outcome Treatment
    1 Other