BD¿ ALCOHOL SWAB
Received Mar 24, 2022 · Event occurred Mar 10, 2022
Report 1920898-2022-00190 · MDR key 13890099
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 THAT THE BD¿ ALCOHOL SWAB EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): THE SACHET CAME WITH THE ASEPTIC PAD OUT OF QUALITY STANDARDS.
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE BD¿ ALCOHOL SWAB EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGESE: THE SACHET CAME WITH THE ASEPTIC PAD OUT OF QUALITY STANDARDS.
Additional Manufacturer Narrative
H.6. INVESTIGATION: CUSTOMER RETURNED AN IMAGE OF AN OPENED ALCOHOL SWAB PACKET AND ITS ASSOCIATED SWAB. THE SWAB ITSELF FEATURES A BAND OF A BANDAGE-LIKE MATERIAL NOT INTENDED FOR USE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #1158448. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF FOREIGN MATTER 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.