BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLE

    MDR report key: 7020781 · Received November 10, 2017

    Report

    Report Number
    1920898-2017-00305
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 18, 2017
    Report Date
    December 18, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K010890
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6326899, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2016-11-21. MEDICAL DEVICE LOT #: 3231095, MEDICAL DEVICE EXPIRATION DATE: 2018-08-31, DEVICE MANUFACTURE DATE: 2013-08-19. MEDICAL DEVICE LOT #: 6235607, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2016-08-22. MEDICAL DEVICE LOT #: 7086628, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2017-03-27. MEDICAL DEVICE LOT #: 7010764, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2017-01-10. MEDICAL DEVICE LOT #: 6195895, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2016-07-13. MEDICAL DEVICE LOT #: 7044949, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2017-02-13. MEDICAL DEVICE LOT #: 6172629, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2016-06-20. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 6326899, (10) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 6235607, (9) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 7010764, AND (10) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 6172629. NO SAMPLES FROM ANY OF THE OTHER REPORTED LOT NUMBERS WERE RETURNED. CUSTOMER STATES THAT NUMEROUS SYRINGES OF DIFFERENT BATCHES HAVE A VISIBLE EXCESS OF SILICONE OIL. ALL RETURNED SYRINGES WERE EXAMINED UNDER THE MICROSCOPE AND 2 OUT OF 10 SAMPLES FROM LOT # 6326899 EXHIBITED A SMALL AMOUNT OF CLEAR MATERIAL INSIDE THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF SILICONE. SEE ATTACHED PHOTO AND SPECTRA. NO OTHER SAMPLES RETURNED BY THE CUSTOMER EXHIBITED ANY LIQUID INSIDE THE BARREL OR ANY OTHER FOREIGN MATTER. THE MANUFACTURING SITE ALSO EVALUATED THE RETURNED SAMPLES. (10) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 6326899, (10) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 6235607, (9) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 7010764, AND (10) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 6172629. NO SAMPLES FROM ANY OF THE OTHER REPORTED LOT NUMBERS WERE RETURNED. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, IT WAS NOTED THAT NO EXCESS SILICONE WAS NOTED WITHIN ANY OF THE SAMPLES RECEIVED. INITIAL ANALYSIS PERFORMED AT FRANKLIN LAKES NOTED TWO (2) SAMPLES EXHIBITING EXCESS SILICONE, WHICH WAS VERIFIED VIA FTIR SPECTRAL ANALYSIS. CAPA (B)(4) WAS INITIATED BY THE (B)(4) PLANT TO ADDRESS EXCESS SILICONE AND IT'S ASSOCIATED ROOT CAUSE(S). ALL BATCHES NOTED WITHIN THIS COMPLAINT WERE MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA. NO ADDITIONAL ACTIONS AT THIS TIME. MEDICAL DEVICE LOT #: 6326899 (SAMPLES RCVD 12/4). INVESTIGATION: DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6326899. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A SPECTROSCOPY WAS PERFORMED FOR BATCH #6326899 AND REVEALED A CLEAR LIQUID DROPLET WAS DETERMINED TO BE SILICONE. MEDICAL DEVICE LOT #: 3231095. INVESTIGATION: DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 3231095. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. MEDICAL DEVICE LOT #: 6235607 (SAMPLES RCVD 12/4). INVESTIGATION: DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6235607. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. MEDICAL DEVICE LOT #: 7086628. INVESTIGATION: DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7086628. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ELEVEN (11) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. MEDICAL DEVICE LOT #: 7010764 (SAMPLES RCVD 12/4). INVESTIGATION: DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7010764. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE NO NOTIFICATIONS NOTED FOR COMPLAINT. MEDICAL DEVICE LOT #: 6195895. INVESTIGATION: DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6195895. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED. MEDICAL DEVICE LOT #: 7044949. INVESTIGATION: DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7044949. 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. MEDICAL DEVICE LOT #: 6172629 (SAMPLES RCVD 12/4). INVESTIGATION: DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6172629. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED NUMEROUS BD MICRO-FINE¿ + INSULIN SYRINGE(S) WITH NEEDLE(S) THAT HAVE VISIBLE SILICONE OIL ON THE NEEDLE. THIS WAS NOTICED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802371 BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other