BD ALCOHOL SWABS

Description of Event or Problem

IT WAS REPORTED THAT BD ALCOHOL SWABS HAD VISIBLE FOREIGN MATTER ON THE PAD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 326895 BATCH NO: 0156803. IT WAS REPORTED THAT THE PATIENT STATED THE PAD TYPICALLY IS "SNOW WHITE," BUT THIS LOT THE PADS ARE BROWN LIKE THEY HAVE BEEN DIPPED IN DIRTY WATER.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/2/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (21) SEALED BD ALCOHOL SWABS (11 FROM LINE 3, 10 FROM LINE 4) FROM LOT # 0156803. CUSTOMER STATES THAT THE PAD TYPICALLY IS "SNOW WHITE," BUT THIS LOT THE PADS ARE BROWN LIKE THEY HAVE BEEN DIPPED IN DIRTY WATER. ALL RETURNED SWAB PADS WERE EXAMINED AND NO DEFECTS WERE OBSERVED ON ANY OF THE RETURNED SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0156803. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

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 BD ALCOHOL SWABS HAD VISIBLE FOREIGN MATTER ON THE PAD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 326895 BATCH NO: 0156803. IT WAS REPORTED THAT THE PATIENT STATED THE PAD TYPICALLY IS "SNOW WHITE," BUT THIS LOT THE PADS ARE BROWN LIKE THEY HAVE BEEN DIPPED IN DIRTY WATER.