BD PROBETEC ET CT/GC AMPLIFIED DNA ASSAY COL

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.