SWAB ALCOHOL
Received Jul 2, 2021 · Event occurred Jun 8, 2021
Report 1920898-2021-00719 · MDR key 12112679
Device
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT 6 SWAB ALCOHOL WIPES HAD FOREIGN MATTER ON THE SWABS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED A BAND AID LIKE SUBSTANCE ON THE SWABS. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-07-27. INVESTIGATION SUMMARY : CUSTOMER RETURNED A TOTAL OF 4 ALCOHOL SWABS FROM LOT 0345772. EACH OF THE SWABS HAS A STRIP OF MESHED MATERIAL ON IT. THE BACK IS COVERED WITH ADHESIVE, CAUSING THEM TO STICK TO THE SWABS. THE MATERIAL IS ALSO CUT WITH A SIMILAR SIZE AND SHAPE TO THE SWABS, FITTING THE TOP 1/3RD OR SO OF THE SWABS. THESE STRIPS ARE QUITE SIMILAR TO THE ADHESIVE PARTS OF BAND-AIDS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0345772. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF FOREIGN MATTER ON THE SWABS. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS PENDING 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 6 SWAB ALCOHOL WIPES HAD FOREIGN MATTER ON THE SWABS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED A BAND AID LIKE SUBSTANCE ON THE SWABS. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT 6 SWAB ALCOHOL WIPES HAD FOREIGN MATTER ON THE SWABS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED A BAND AID LIKE SUBSTANCE ON THE SWABS. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.
Additional Manufacturer Narrative
H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #0345772. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.