HEMOSTATIC Y SETS
Received Jan 9, 2025 · Event occurred Nov 14, 2024
Report 9616567-2025-00006 · MDR key 21117995
Device
Generic name
Bag, Hemostatic
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
B1336LBNL
Lot number
6034513
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D4 - EXPIRATION DATE, D4 - PRIMARY UDI NUMBER, H5 - LABELED FOR SINGLE USE AND H4 - DEVICE MFG DATE: CORRECTION. H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT ONE SAMPLE CAP DETACHED WHEN LOOSENED. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO HARM/ADVERSE EVENT REPORTED.