SWAB ALCOHOL 100 BX 1200
Received Jun 9, 2020 · Event occurred May 9, 2020
Report 1920898-2020-00648 · MDR key 10135734
Device
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
H.6. INVESTIGATION: CUSTOMER RETURNED (1) OPEN BD ALCOHOL SWAB FROM LOT # 8333501 (FROM LINE 3). CUSTOMER STATES THAT THERE IS DISCOLORATION ON THE SWAB. THE RETURNED SWAB WAS EXAMINED AND EXHIBITED A YELLOWISH DISCOLORATION OF THE SWAB PAD THAT APPEARS TO BE ABSORBED INTO THE SWAB PAD MATERIAL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8333501. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. PROCESS: AT THE SWAB MACHINES, WHEN A NEW ROLL OF MATERIAL (PAD AND OR FOIL) IS INTRODUCED, THE MATERIAL IS SPLICED TOGETHER WITH TAPE TO THE PREVIOUS ROLL TO AIDE IN CYCLING THE MATERIAL THROUGH THE MACHINE. THE TAPE IS MANUALLY APPLIED, BY THE SWAB ASSOCIATE, ONTO THE END OF THE ROLL THAT IS ON THE MACHINE AND ONTO THE NEW ROLL THAT IS BEING INTRODUCED. AN EYE (SICK EYE) ON EACH SIDE OF THE PAD ROLL (LANE 1 & LANE 10) IS USED TO DETECT THE TAPED SPLICE. WHEN THE EYE DETECTS THE SLICE, IT COUNTS (SO MANY CYCLES) AND AUTOMATICALLY REJECTS THE SWABS, PRIOR TO THE CARTON AN ACCUMULATOR INTO A WASTE BIN. INVESTIGATION: THE DHR, L2L DISPATCHES, LOGBOOKS AND QUALITY NOTIFICATIONS WERE ALL REVIEWED. NOTHING WAS FOUND PERTAINING TO THIS TYPE OF COMPLAINT. ROOT CAUSE: THIS IS THE 1ST RELATED COMPLAINT FOR DISCOLORED ON LOT #8333501. SINCE THE STAIN ON THE POUCH COULD NOT BE SEPARATED TO BE TESTED, ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.
Description of Event or Problem
IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 WAS DISCOLORED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 326895 BATCH NO: 8333501. CONSUMER REPORTED DISCOLORATION ON SWAB.
Additional Manufacturer Narrative
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 WAS DISCOLORED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 326895 BATCH, NO: 8333501. CONSUMER REPORTED DISCOLORATION ON SWAB.