LAP SPONGES
Received Jan 28, 2010 · Event occurred Aug 3, 2009
Report 2083545-2010-00001 · MDR key 1603374
Device
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
NO RETURNED SAMPLE FROM THE (B)(6) HOSPITAL OF (B)(6) WAS AVAILABLE IN CONNECTION TO THE MEDWATCH REPORT. SOME STERILE LAP SPONGE PACK SAMPLES FROM THE SAME LOT NUMBER WERE RETURNED BY THE (B)(6) HOSPITAL RECENTLY. HOWEVER, WE CANNOT BE SURE THAT THE SAMPLES WERE RELATED TO THE RECENT MEDWATCH REPORT. SAMPLES FROM LOT NUMBER 7408 PREVIOUSLY RETURNED FROM THE (B)(6) HOSPITAL WERE CAREFULLY EXAMINED. NO LINT OR LOOSE ATTACHED THREAD THAT MIGHT BE DESCRIBED AS "LINT" WAS FOUND IN THE RETURNED UNOPENED PACKAGES OF THE STERILE LAP SPONGES. SOME PACKAGES WERE ALSO OPENED TO CHECK THE LAP SPONGES, NO NONCONFORMING CONDITION WAS DISCOVERED. WE ALSO CHECKED THE PRODUCTION AND QUALITY RECORDS (INCLUDING THE USP GAUZE MONOGRAPH TEST RESULTS) FOR THE LOT NUMBER IN QUESTION, AND NO NONCONFORMING CONDITION WAS FOUND. WE ALSO CHECKED THE CUSTOMER COMPLAINT TRENDING RECORDS, AND NO OTHER SIMILAR COMPLAINT WAS REPORTED BY OTHER CUSTOMERS ON THIS LOT NUMBER OF LAP SPONGES. (B)(4). HOWEVER, THIS DOES NOT AFFECT THE SAFETY AND INTENDED USE OF THE PRODUCTS.
Description of Event or Problem
EVENT DESC: UNOPENED PACKAGES OF STERILE LAP SPONGES CONTAIN LINT. DEVICE USAGE PROBLEM: OTHER.