BD ALCOHOL SWAB 100 PACK

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11/29/2021. H.6. INVESTIGATION: CUSTOMER RETURNED TWO OPENED ALCOHOL SWAB PACKETS FROM LOT 1005039. BOTH SWABS WITHIN THE PACKETS HAVE A NOTABLE BROWNISH STAIN ON THEIR SURFACES, WITH ONE SIGNIFICANTLY LARGER THAN THE OTHER. ADDITIONALLY, THERE SEEMS TO BE MUCH MORE OF THIS STAINING ON ONE SIDE THAN THE OTHER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #1005039. 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 SWAB. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED BD ALCOHOL SWAB 100 PACK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MY HUSBAND IS DIABETIC AND USES YOUR ALCOHOL SWABS. IN ONE BOX THAT HE RECENTLY OPENED ALL THE SWABS ARE DISCOLOURED (LOOK DIRTY)."

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1005040. D.4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2023. H.4. DEVICE MANUFACTURE DATE: 1/5/2021. D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. D.4. MEDICAL DEVICE LOT #: 1005039. D.4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2023. H.4. DEVICE MANUFACTURE DATE: 1/5/2021. 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 MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THESE LOTS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED BD ALCOHOL SWAB 100 PACK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MY HUSBAND IS DIABETIC AND USES YOUR ALCOHOL SWABS. IN ONE BOX THAT HE RECENTLY OPENED ALL THE SWABS ARE DISCOLOURED (LOOK DIRTY)."

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 BD ALCOHOL SWAB 100 PACK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MY HUSBAND IS DIABETIC AND USES YOUR ALCOHOL SWABS. IN ONE BOX THAT HE RECENTLY OPENED ALL THE SWABS ARE DISCOLOURED (LOOK DIRTY)."