BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 8MM 90 BX 450 MO

    MDR report key: 11070646 · Received December 24, 2020

    Report

    Report Number
    1920898-2020-01759
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    November 28, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-12-28. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 3/10CC, 8MM, 31G SYRINGES IN AN OPEN POLY BAG WITH THE SHELF CARTON FROM LOT # 0090638. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATES WHEN SHIELD IS REMOVED. BOTH RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE WAS RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. NO DEFECTS WERE OBSERVED ON THE REMAINING SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0090638 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR OUT OF SPEC SHIELD PULL. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE THAT THE NEEDLE HUB SEPARATES WHEN SHIELD IS REMOVED. ROOT CAUSE COULD NOT BE DETERMINED. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 8MM 90 BX 450 MO SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATES WHEN SHIELD IS REMOVED. THIS (B)(4) RECORDS ISSUE OF SEPARATES FOR AWARENESS DATE OF (B)(6) 2020. SEE (B)(4) THAT RECORDS ISSUE OF SEPARATES FOR AWARENESS DATE OF (B)(6) 2020. VERBATIM: FROM PHONE CALL ON (B)(6) 2020 12:29:32: CONSUMER REPORTED CALLING BACK CALL FROM BD COM OUTGOING CALL. STATED HAS A 3RD SYRINGE FROM THIS SAME BOX TO REPORT. HAS 2 OUT OF 3 SYRINGES TO RETURN WITH SAME ISSUES. NEEDLE HUB STAYS IN SHIELD WHEN SHIELD REMOVED. OBTAINED THE MAILING INFO TO GET PRODUCTS BACK WITH MAILKIT AND VOUCHER LOT # 0090638 A. CATALOG# 328291. DATE OF EVENT (B)(6) 2020 FOR THE SAMPLE STATUS AWAITING SAMPLE DC. INFORMATION FROM EMAIL BELOW: EMAIL RECEIVED 2020-11-29 17:18:03. SENT: SATURDAY, NOVEMBER 28, 2020 10:50 AM. LOT NUMBER- 0090638 A. MFG DATE- 2020-05-01. EXP DATE 2025-04-30. "NO HARM. ISSUE IS THAT THE NEEDLE TIP SEPARATES WITH THE CAP WHEN YOU REMOVE THE CAP FROM THE BARREL. THIS HAS HAPPENED ON TWO SYRINGES FROM THE SAME BAG ALREADY. POTENTIAL HARM: IF YOU DO NOT HAVE EXTRA SYRINGES YOU WOULD BE IN A SITUATION WHERE YOU COULD NOT ADMINISTER YOUR INSULIN. A SAMPLE DEFECT IS AVAILABLE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE 0.3ML 8MM 90 BX 450 MO SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATES WHEN SHIELD IS REMOVED. THIS (B)(4) RECORDS ISSUE OF SEPARATES FOR AWARENESS DATE OF (B)(6) 2020. SEE (B)(4) THAT RECORDS ISSUE OF SEPARATES FOR AWARENESS DATE OF 03DEC2020. VERBATIM: FROM PHONE CALL ON 2020-12-03 12:29:32: CONSUMER REPORTED CALLING BACK CALL FROM BD COM OUTGOING CALL. STATED HAS A 3RD SYRINGE FROM THIS SAME BOX TO REPORT. HAS 2 OUT OF 3 SYRINGES TO RETURN WITH SAME ISSUES. NEEDLE HUB STAYS IN SHIELD WHEN SHIELD REMOVED. OBTAINED THE MAILING INFO TO GET PRODUCTS BACK WITH MAILKIT AND VOUCHER. LOT # 0090638 A. CATALOG# 328291. DATE OF EVENT (B)(6) 2020 FOR THE SAMPLE STATUS AWAITING SAMPLE. INFORMATION FROM EMAIL BELOW: EMAIL RECEIVED"2020-11-29 17:18:03. SENT: SATURDAY, (B)(6) 2020 10:50 AM. LOT NUMBER- 0090638 A. MFG DATE- 2020-05-01. EXP DATE 2025-04-30. "NO HARM. ISSUE IS THAT THE NEEDLE TIP SEPARATES WITH THE CAP WHEN YOU REMOVE THE CAP FROM THE BARREL. THIS HAS HAPPENED ON TWO SYRINGES FROM THE SAME BAG ALREADY. POTENTIAL HARM: IF YOU DO NOT HAVE EXTRA SYRINGES YOU WOULD BE IN A SITUATION WHERE YOU COULD NOT ADMINISTER YOUR INSULIN. A SAMPLE DEFECT IS AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537216 SYRINGE 0.3ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 0090638 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1