RSP 4.0MM TAPERED TIP 6BOX ST
Received Dec 5, 2024 · Event occurred Nov 18, 2024
Report 0001032347-2024-00367 · MDR key 20853102
Device
Generic name
Aorta Punch, Single-use
Manufacturer
A&e Medical CorporationModel number
NICatalog number
080-403
Lot number
24991
Product problems
- Packaging Problem
- Packaging Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4). G2: JAPAN CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS FOUND IN THE DEVICE PACKAGING AT THE DISTRIBUTORSHIP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.