REMEL SWAB PACK COMBO
Received Nov 3, 2004 · Event occurred Oct 20, 2004
Report 1924669-2004-00001 · MDR key 900296
Device
Generic name
Single Use Disposable Sample Collection Swab
Manufacturer
Remel, Inc.Model number
*Catalog number
*
Lot number
8154
Product problems
- Material Separation
- Device, removal of (non-implant)
Patient
52 YR
- Foreign body, removal of
- Surgical procedure, additional
Narrative
Additional Manufacturer Narrative
THE REPORTED DEFECTIVE COMPONENT IS MFR FOR REMEL INC BY A SUB-CONTRACTOR. THE SUBCONTRACTOR HAS BEEN NOTIFIED OF THIS INCIDENT AND HAS PROVIDED REMEL INC WITH THE QC TESTING PROCEDURE FOR THE BOND BETWEEN THE SWAB TIP MATERIAL AND THE SWAB HANDLE. THE SUB-CONTRACTOR REPORTS THE STRENGTH OF THIS BOND IS MEASURED BOTH IN THE ASSEMBLY PROCESS AND AS PART OF THE FINAL BATCH QC TEST/RELEASE PROCEDURE. BOTH TEST ARE REPORTED TO HAVE BEEN SUCCESSFULLY COMPLETED FOR THE BATCH AT ISSUE AND THE BATCH WAS RELEASED ACCORDINGLY. THE AQL FOR THIS ATTRIBUTE, AS REPORTED BY THE SUB-CONTRACTOR IS, 0.04%. THIS PARTICULAR DEVICE WAS ONE OF A LOT THAT HAS BEEN IN THE DISTRIBUTION CHAIN SINCE 2004. THE RATE OF USAGE WOULD SUGGEST THIS LOT IS DEPLETED. THIS IS THE FIRST REPORT OF FAILURE OF SWABS MFR BY THIS SUB-CONTRACTOR. AS OF THIS TIME, THIS INCIDENT IS CONSIDERED TO BE AN ISOLATED OCCURRENCE.
Description of Event or Problem
THE HOSP REPORTS THAT THE PT WAS UNDERGOING A NORMAL PROCEDURE FOR COLLECTION OF SPECIMEN SAMPLE FROM THE URETHRA/BLADDER. WHEN THE DEVICE (MALE SWAB) WAS REMOVED FROM THE PT, THE COTTON TIP OF THE SWAB SEPARATED FROM THE SWAB HANDLE AND WAS RETAINED IN THE PT'S URETHRA. THE PT SUBSEQUENTLY UNDERWENT A SUCCESSFUL URETROSCOPY TO REMOVE THE COTTON SWAB TIP."