BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 G X 1 1/2 IN. BD¿ BLUNT FILTER NEEDLE

    MDR report key: 7006987 · Received November 7, 2017

    Report

    Report Number
    1911916-2017-00309
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 13, 2017
    Report Date
    December 11, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7059559, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2017-02-28. MEDICAL DEVICE LOT #: 7023633, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2017-01-23. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TWO BAGS OF SALINE SOLUTION WERE RETURNED TO THE (B)(4) PLANT FOR EVALUATION. THEY WERE INSPECTED WITH THE NAKED EYE, AND A 10X MICROSCOPE. NO FOREIGN MATTER WAS OBSERVED IN THE BAGS OF SOLUTION, THEREFORE FAILURE MODE IS NOT CONFIRMED. DHR REVIEW: BATCH 7059559 ¿ FORTY-FIVE VISUAL INSPECTIONS WERE PERFORMED ON 2,700 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED SEVEN TIMES DURING THE PACKAGING OF THIS BATCH. ASSEMBLY BATCH 7060582 HAD 156 VISUAL INSPECTIONS PERFORMED ON 7,950 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED 19 TIMES DURING THE ASSEMBLY OF THIS BATCH. BATCH 7023633 ¿ THIRTY-FIVE VISUAL INSPECTIONS WERE PERFORMED ON 2,100 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED FIVE TIMES DURING THE PRODUCTION OF THIS BATCH. ASSEMBLY BATCH 7024533 HAD 156 VISUAL INSPECTION PERFORMED ON 7,950 PARTS WITH ZERO DEFECTS NOTED FOR FM. CLEANING WAS PERFORMED 24 TIMES DURING THE ASSEMBLY OF THIS BATCH. ALL CLEANING WAS PERFORMED PER PROCEDURE. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THESE BATCHES, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THESE BATCHES, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION RESULTS: TWO BAGS OF SALINE SOLUTION WERE RETURNED. THEY WERE INSPECTED WITH THE NAKED EYE, AND A 10X MICROSCOPE. NO FOREIGN MATTER WAS OBSERVED IN THE BAGS OF SOLUTION. POSSIBLE ROOT CAUSE: THE DEFECT COULD NOT BE CONFIRMED ¿ NOT APPLICABLE. INVESTIGATION RESULTS: TWO BAGS OF SALINE SOLUTION WERE RETURNED. THEY WERE INSPECTED WITH THE NAKED EYE, AND A 10X MICROSCOPE. N FOREIGN MATTER WAS OBSERVED IN THE BAGS OF SOLUTION. POSSIBLE ROOT CAUSE: THE DEFECT COULD NOT BE CONFIRMED ¿ NOT APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE 18 G X 1 1/2 IN. BD¿ BLUNT FILTER NEEDLE(S), FOREIGN MATTER (PARTICLES) ARE RELEASED DURING USE. THESE PARTICLES WERE FOUND IN THE INFUSION BAGS AFTER USING THE NEEDLES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787707 18 G X 1 1/2 IN. BD¿ BLUNT FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other