BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ¿ INSULIN SYRINGE

    MDR report key: 7358398 · Received March 21, 2018

    Report

    Report Number
    1920898-2018-00165
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    March 12, 2018
    Report Date
    May 11, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TWO INVESTIGATIONS WERE CARRIED OUT. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED (20) LOOSE 1CC, 12.7MM SYRINGES FROM LOT # 7142919. CUSTOMER STATES THAT THE NEEDLE COMES OUT WHEN OPENING THE BLISTER. TWO SYRINGES WERE RETURNED WITH A BROKEN PIECE OF THE BARREL TIP ALONG WITH THE CANNULA STUCK IN THE SHIELD AND SEPARATED FROM THE REST OF THE BARREL. NO DEFECTS WERE OBSERVED ON ANY OTHER SYRINGES. SAMPLES WERE FORWARDED TO MANUFACTURING ((B)(4)) ON 06APR2018 FOR FURTHER REVIEW. SECOND INVESTIGATION SUMMARY: ON 10APR2018, (B)(4) RECEIVED TWENTY (20) LOOSE 1ML, 12.7MM SYRINGES FROM REPORTED BATCH# 7142919. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE (B)(4), SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD (B)(4) WERE NOTED. PROBABLE ROOT CAUSE FOR THE BROKEN BARREL TIPS IS LIKELY TO BE A JAW JAM ON THE FORM FILL & SEAL (FFS) EQUIPMENT DURING PACKAGING OF SYRINGES INTO POLYBAGS. WHEN THIS TYPE OF EVENT OCCURS, ANY PORTION OF THE SYRINGE OR ITS COMPONENTS MAY BE INVOLVED IN THE JAM AND CAN BE DAMAGED TO VARYING DEGREES, INCLUDING BROKEN BARREL TIPS AS ARE SEEN IN THE RECEIVED SAMPLES. THE RESULTING DAMAGED COMPONENTS OR SYRINGES CAN POTENTIALLY MAKE THEIR WAY TO THE CONSUMER WITHOUT BEING DETECTED DURING IN-LINE INSPECTIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7142919. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SEVEN (7) NOTIFICATIONS [200701707, 200701669, 220701725, 200701668, 200701667, 200701590, 200701599] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7142919. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN BARREL). POSSIBLE ROOT CAUSE FOR BROKEN BARREL TIP: CAN BE CAUSED BY THE TAMPING OF THE PACKAGES WITHIN THE CARTON TO ALLOW CLOSURE OF THE CARTON.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD MICRO-FINE ¿ INSULIN SYRINGE ¿WHEN OPENING THE BLISTER PACKAGING THE NEEDLE WAS SEPARATED FROM THE SYRINGE.¿ THE CONSUMER IS CONCERNED AND FEELS THERE IS A RISK FOR A RETAINED NEEDLE IF USED¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199790 BD MICRO-FINE ¿ INSULIN SYRINGE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7142919

    Patients

    Seq Age Sex Outcome Treatment
    1 Other