BD SWAB ALCOHOL 100 BX 1200 SPAIN
Received Oct 1, 2022 · Event occurred Sep 13, 2022
Report 1920898-2022-00669 · MDR key 15524835
Device
Generic name
Pad, Alcohol, Device Disinfectant
Manufacturer
Bd Medical - Diabetes CareCatalog number
326899
Lot number
2094439
Product problems
- Illegible Information
- Illegible Information
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN; AWARENESS DATE 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.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD SWAB ALCOHOL 100 BX 1200 SPAIN THE LABEL INFORMATION WAS ILLEGIBLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MATERIAL DAMAGED. THE BATCH AND EXPIRATION CODE IS NOT READABLE IN THE SHELFPACK, IT DOES NOT HAVE ALL THE NUMBERS PRINTED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD SWAB ALCOHOL 100 BX 1200 SPAIN THE LABEL INFORMATION WAS ILLEGIBLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: MATERIAL DAMAGED. THE BATCH AND EXPIRATION CODE IS NOT READABLE IN THE SHELFPACK, IT DOES NOT HAVE ALL THE NUMBERS PRINTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. SEVERAL PHOTOS OF THE ALCOHOL SWAB 100 BOX SHELF CARTONS WERE PROVIDED. THE CUSTOMER REPORTED THE BATCH AND EXPIRATION CODE ARE NOT READABLE IN THE SHELFPACK, IT DOES NOT HAVE ALL THE NUMBERS PRINTED. THE IMAGES WERE EXAMINED, AND IT WAS OBSERVED THAT THE PRINTED LOT NUMBER, MANUFACTURING DATE, AND EXPIRATION DATE IS PARTIALLY VISIBLE MAKING THE PACKAGE PRINTING UNCLEAR AND THE DETAILS DIFFICULT TO READ. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2094439. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE IMAGE RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF PACKAGE PRINTING DEFECT (NOT READABLE). THERE WERE NO QUALITY NOTIFICATIONS OR DISPATCHES THAT PERTAINED TO THIS COMPLAINT; THEREFORE, NO ROOT CAUSE CAN BE DETERMINED. H3 OTHER TEXT : SEE H10.