KIT AFFIRM ATT SYSTEM 100 EA
Received Nov 30, 2023 · Event occurred Sep 13, 2023
Report 1119779-2023-01282 · MDR key 18243294
Device
Generic name
Device, Specimen Collection
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
446255
Lot number
UNKNOWN
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Unknown
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION SUMMARY: BD INTEGRATED DIAGNOSTIC SOLUTIONS INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING GLASS USER INJURY WHILE USING THE AFFIRM ATTS (CATALOG # 446255), BATCH # UNKNOWN. PREVIOUS INVESTIGATION DID NOT REVEAL ANY CHANGES TO MATERIALS THAT COULD DIRECTLY CAUSE THIS INJURY. A REVIEW OF PAST COMPLAINTS DOES NOT INDICATE TREND BY ATTS BATCH. BD IMPLEMENTED THE PACKAGING OF THE ATTS AMPULE CRUSHING TOOL IN ORDER TO PREVENT FUTURE OCCURRENCE OF THIS ISSUE. ALL CURRENT ATTS KITS CONTAIN 1 TOOL WHICH WILL BE PROVIDED IN EACH KIT INDEFINITELY. PER PACKAGE INSERT INSTRUCTIONS, WE WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH ATTS GLASS INJURY.
Description of Event or Problem
IT HAS BEEN REPORTED THAT THE KIT AFFIRM ATT SYSTEM 100 EA HAS BEEN FOUND WITH THE AMPULE PUNCTURING SKIN DURING USE. NO SERIOUS INJURY WAS REPORTED, FIRST AIDE PROVIDED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: AFF 446255 INJURY WHEN BREAKING THE AMPULE. CUSTOMER REPORTS AN INJURY WHEN BREAKING THE AMPULE: A SMALL PINPOINT BREAK IN SKIN. FIRST AIDE PROVIDED (CLEANSED AND BAND AID APPLIED); NO FURTHER TREATMENT REQUIRED.