BD ALCOHOL SWAB 100 PACK
Received Mar 16, 2022 · Event occurred Mar 2, 2022
Report 1920898-2022-00166 · MDR key 13777529
Device
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED BD ALCOHOL SWAB 100 PACK CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED, WHEN HE OPENS A PACKAGE OF ALCOHOL SWABS, THERE IS A BROWN FILM ON THE SWABS.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative
H.6. INVESTIGATION: CUSTOMER RETURNED AN IMAGE OF AN ALCOHOL SWAB AND ITS PACKET FROM LOT 1077178. THE ALCOHOL SWAB FEATURES A STRIP OF BAND-AID LIKE MATERIAL THAT COVERS ABOUT TWO THIRDS OF THE SWAB. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #1077178. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF FOREIGN MATERIAL ON THE SWAB. ROOT CAUSE: WHEN ONE ROLL OF PAD MATERIAL RUNS OUT, ANOTHER ROLL IS SPLICED TO IT USING TAPE. THE PRODUCT WAS NOT DISCARDED AFTER THE PAD ROLL WAS CHANGED. H3 OTHER TEXT : SEE H.10.
Description of Event or Problem
IT WAS REPORTED BD ALCOHOL SWAB 100 PACK CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED, WHEN HE OPENS A PACKAGE OF ALCOHOL SWABS, THERE IS A "BROWN FILM" ON THE SWABS."