BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE PERMANENTLY ATTACHED NEEDLE

    MDR report key: 9081491 · Received September 18, 2019

    Report

    Report Number
    1920898-2019-01003
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 30, 2019
    Report Date
    October 3, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903055402
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1000) BD ALLERGY SYRINGES IN TRAYS FROM LOT # 8059820 IN A SHIPPING CARTON FROM LOT # 8113644. CUSTOMER STATES THAT ONE OF THE FOUR CASES HAD ½ ML NEEDLES AND NOT 1 ML HOWEVER, THE LABEL STATES 1 ML. THE RETURNED SHIPPING CARTON WAS EXAMINED AND HAD LABELS INDICATING 1ML, 13MM, 27G BD ALLERGY SYRINGES FROM CAT # 305540, LOT # 8113644 ON THE SHIPPING CARTON. THE TRAYS WERE ALSO EXAMINED AND INDICATED 1/2ML, 10MM, 27G BD ALLERGY SYRINGES FROM CAT # 305536, LOT # 8059820. THE SYRINGES IN THE TRAYS WERE OBSERVED TO BE 1/2ML, 10MM, 27G. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8113644. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. 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. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "PROBLEM STATEMENT: MISLABELING OF THE PRODUCT WAS INITIALLY REPORTED WITHIN A COMPLAINT STATING THAT ONE OF FOUR CASES HAD THE TRAYS (CARTON) LABELED AS ¿BD ALLERGY 0.5ML 27X3/8IN IB (25 TRAY 1000)¿, CATALOG# 305536. THE OUTER CASE WAS LABELED AS ¿BD ALLERGY 1ML 27X1/2IN RB (25 TRAY 1000)¿, CATALOG# 305540. PRODUCT CONTAINED IN THE TRAYS WAS VERIFIED TO BE THE CORRECT PRODUCT (ALLERGY 0.5ML 27X3/8IN IB) AND IN THE CORRECT TOP WEB MATERIAL. RECORD REVIEW INCLUDING LINE CLEARANCE & REVIEW OF PRODUCTION DATES: ON 17MAY2018, FINAL PACKAGING OF CAT# 305536 BATCH# 8059830 WAS INITIATED AND ONE PALLET WAS PRODUCED BEFORE CHANGING OVER DUE TO SCHEDULING DEMANDS. CAT# 305536 BATCH# 8059820 RESUMED ON 23MAY2018 AND COMPLETED ON 25MAY2018. QUANTITY COMPLETED 767,000. THE LOT (AMT. (B)(4)) WAS STERILIZED ON 05JUNE2018 AND SHIPPED TO FOUR OAKS (AMT. 227,000), REDLANDS (AMT. (B)(4)), AND PLAINFIELD (AMT (B)(4)) ON 06JUN2018-07JUN2018. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#8059830. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THERE IS NO EVIDENCE OF PRODUCT DESTROYED OR SORTED. AMT. (B)(4) WAS CONFIRMED TO BE STERILIZED AND AMT 767,000 WAS CONFIRMED SHIPPED FOR CAT# 305536 BATCH# 8059830. ON 13JUN2018 FINAL PACKAGING OF CAT# 305540 BATCH# 8113611 WAS INITIATED AND COMPLETED ON JUNE 14TH,2018. QUANTITY COMPLETED WAS (B)(4). THE AMOUNT (B)(4) WAS STERILIZED ON JUNE 18, 2018 AND SHIPPED ONLY TO FOUR OAKS (AMT. (B)(4)) ON 19JUN2018. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#8113611. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THERE IS NO EVIDENCE OF PRODUCT DESTROYED OR SORTED. AMT. (B)(4) WAS CONFIRMED TO BE STERILIZED AND AMT (B)(4) WAS CONFIRMED SHIPPED FOR CAT# 305540 BATCH# 8113611. RESULTS OF PRODUCTION EVALUATION BASED OFF THE PACKAGING PRODUCTION TIME FRAME THE MIX COULD NOT HAVE OCCURRED AT BD HOLDREGE. CAT# 305536 BATCH# 8059830 WAS MADE AND SHIPPED OUT OF THE PLANT 8 DAYS BEFORE THE PRODUCTION OF CAT# 305540 BATCH# 8113611 OCCURRED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE INVESTIGATED FOR THE POTENTIAL MIXED PRODUCT OPPORTUNITIES OUTSIDE OF BD HOLDREGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ½ ML NEEDLES WERE FOUND IN A CASE OF 1 ML LABELED BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT ONE OF THE FOUR CASES HAD ½ ML NEEDLES AND NOT 1 ML HOWEVER, THE LABEL STATES 1 ML WITH BD SYR PN 1CC 27G X 1/2 , 25/TR 40 TR/CA (1000) (ITEM# BD5540 LOT# 8113644).

    Additional Manufacturer Narrative · 1

    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 THAT ½ ML NEEDLES WERE FOUND IN A CASE OF 1 ML LABELED BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT ONE OF THE FOUR CASES HAD ½ ML NEEDLES AND NOT 1 ML HOWEVER, THE LABEL STATES 1 ML WITH BD SYR PN 1CC 27G X 1/2 , 25/TR 40 TR/CA (1000) (ITEM# BD5540, LOT# 8113644).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878901 BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE PERMANENTLY ATTACHED NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8113644 30382903055402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other