PORT ACCESS KIT
Received Apr 10, 2024 · Event occurred Mar 12, 2024
Report 3004519921-2024-00021 · MDR key 19080734
Device
Generic name
Port Access Kit
Manufacturer
Productos Medline S.a. De C.v.Catalog number
DYNDA1433A
Lot number
23IBF103
Product problems
- Manufacturing, Packaging or Shipping Problem
- Manufacturing, Packaging or Shipping Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED WHEN OPENING A KIT ON (B)(6) 2024 FOR A "PORT CHANGE", THE "10 ML FLUSH WAS MISSING A PIECE AND DID NOT HAVE ANY FLUID". TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED WHEN OPENING A KIT ON (B)(6) 2024 FOR A "PORT CHANGE", THE "10 ML FLUSH WAS MISSING A PIECE AND DID NOT HAVE ANY FLUID".
Additional Manufacturer Narrative
UPDATE TO D3: MANUFACTURER. REGISTRATION FEI NUMBER: (B)(4).