BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PROBETEC ET CT/GC AMPLIFIED DNA ASSAY COL

    MDR report key: 1297464 · Received January 8, 2009

    Report

    Report Number
    1119779-2009-00001
    Event Type
    Other
    Date Received
    January 8, 2009
    Date of Event
    December 9, 2008
    Report Date
    January 8, 2009
    Manufacturer
    PURITAN MEDICAL PRODUCTS CO. LLC.
    Product Code
    LSL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT HAVE THE LOT NUMBER FROM THE OUTER PACKAGING. IT WAS ACCIDENTLY DISCARDED BY THE SITE. THE CUSTOMER WAS ABLE TO PROVIDE TWO SWAB DILUENT BATCHES THAT ARE PACKAGED WITH THE SWABS. QUALITY USED THESE LOT NUMBERS TO ISOLATE THE INVESTIGATION TO FOUR KIT LOT NUMBERS. SINCE QUALITY WAS UNABLE TO ISOLATE THE LOT NUMBER FURTHER, ALL FOUR KIT LOTS WERE EXAMINED FOR THE DEFECT. THE DEVICE HISTORY RECORDS, INCOMING INSPECTIONS RECORDS, AND RETENTION SAMPLES WERE EXAMINED FOR SWAB TIP COMING OFF FOR KIT LOTS 8157878, 8179145, 8217026, AND 8212939. NO ANOMALIES WERE NOTED AND NO LOOSE SWABS WERE FOUND. SWABS USED TO MANUFACTURE THESE LOTS WERE SWAB (B)(4), LOT NUMBERS 14038 AND 14018. CERTIFICATES OF COMPLIANCE WERE RECEIVED FROM THE SUPPLIER OF THE SWABS, PURITAN. THE SUPPLIER WAS NOTIFIED OF THE CUSTOMER COMPLAINT. BD WAS UNABLE TO CONFIRM THE ISSUE, BUT WILL CONTINUE TO TREND ON THIS TYPE OF DEFECT.

    Description of Event or Problem · 1

    DURING SAMPLE COLLECTION BY A NURSE MIDWIFE ON (B)(6) 2008, THE FOAM TIP OF THE SWAB CAME OFF INSIDE THE PT WHILE COLLECTING AN ENDOCERVICAL SPECIMEN. THE MIDWIFE INSERTED THE SWAB AND TWISTED IT AROUND AS SHE NORMALLY DOES, AND WHEN SHE WENT TO PULL OUT THE SWAB, THE TIP WAS MISSING. THE PT WAS SENT FOR A HYSTEROSCOPY AND D&C WAS PERFORMED. THE SWAB TIP COULD NOT BE LOCATED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PROBETEC ET CT/GC AMPLIFIED DNA ASSAY COL LSL PURITAN MEDICAL PRODUCTS CO. LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other