SWAB ALCOHOL 100 BX 1200

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 HAD DARK SPOTS ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 326895 BATCH NO. 0073322. IT WAS REPORTED THAT SWABS HAVE DARK SPOTS ON THEM.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-10-01. H6: INVESTIGATION SUMMARY. CUSTOMER RETURNED (23) BD ALCOHOL SWABS (1 OPEN, 22 SEALED) FROM LOT # 0073322. CUSTOMER STATES THAT SWABS HAVE DARK SPOTS ON THEM. THE OPEN SWAB WAS EXAMINED AND EXHIBITED BROWN MATERIAL ON THE SWAB PAD. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY POLYETHYLENE TEREPHTHALATE (PET). A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0073322. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200874594] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 HAD DARK SPOTS ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 326895 BATCH NO. 0073322. IT WAS REPORTED THAT SWABS HAVE DARK SPOTS ON THEM.