SWAB ALCOHOL 100 PACK CANADA
Received Mar 26, 2024
Report 1920898-2024-05065 · MDR key 18983549
Device
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION G1 CORRECTED CITY TO (B)(6). SECTION G6 UPDATED TO FOLLOW UP 1 COMPLETED SECTION H6 INVESTIGATION SUMMARY NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE. ROOT CAUSE WAS DETERMINED AND COMMUNICATION WAS PROVIDED BY THE GLOBAL REGULATORY LABELING TEAM ON MARCH 11, 2024, THAT THE GRAPHIC IN QUESTION ((B)(4)) HAD A REVISION DRAFTED AS PART OF THE ONGOING EMBECTA REBRANDING PROCESS. THROUGH THIS PROCESS, THE AFFECTED GRAPHIC WILL BE UPDATED AND CORRECTED TO POSSESS THE CORRECT TRANSLATION ¿USAGE EXTERNE SUELEMENT¿. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.
Description of Event or Problem
¿ ISSUE: THE SHIPPER/CASE FOR SKU (B)(4) STATES ¿FOR EXTREME USE ONLY¿ IN FRENCH WHEN IT SHOULD STATE ¿FOR EXTERNAL USE ONLY¿ IN FRENCH. THE ENGLISH STATEMENT IS CORRECT. OTHER LEVELS OF PACKAGING, SUCH AS THE POUCH AND SHELF CARTON, INCLUDE THE CORRECT STATEMENT IN BOTH ENGLISH AND FRENCH. ¿ HOW THE ISSUE WAS IDENTIFIED: THE ISSUE WAS IDENTIFIED BY A CROSS-FUNCTIONAL EMBECTA TEAM (INTERNAL) THAT WAS REVIEWING/UPDATING ALCOHOL SWAB LABELING MOCKUPS FOR REGULATORY SUBMISSION IN CANADA IN ACCORDANCE WITH PHASE 2 OF EMBECTA¿S GLOBAL REGULATORY TRANSITION PLAN AS PART OF THE SEPARATION FROM BD. ¿ USER IMPACT: THIS STATEMENT ERROR IN THE SHIPPER/CASE COULD CAUSE THE USER TO HAVE AN INCORRECT UNDERSTANDING OF THE PRODUCT¿S INTENDED USE (THAT IT IS TO BE USED FOR EXTREME USE ONLY WHEN IT IS ACTUALLY TO BE USED FOR EXTERNAL USE ONLY).
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H11. CORRECTION TO: H6 (COMPONENT CODE). INVESTIGATION SUMMARY: ADDITIONAL INFORMATION RECEIVED, SITUATION ANALYSIS BDDC-24-5017-SA WAS OPENED TO ADDRESS THIS COMPLAINT.