CAP CHANGE KIT
Received Oct 17, 2023 · Event occurred Jul 26, 2023
Report 1417592-2023-00414 · MDR key 17950299
Device
Generic name
Cap Change Kit
Manufacturer
Medline Industries LpCatalog number
DYNDC2002A
Lot number
23CBQ551
Product problems
- Crack
- Crack
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED BY THE CUSTOMER CONTACT THAT ON (B)(6)23 "TRANSDUCER AND PRIMARY TUBING CONNECTED TO CAP WHEN FOUND TO BE CRACKED ALONG WITH, MICROBORE TUBING AND A PALL FILTER CONNECTED FARTHER UP THE LINE FOR MEDICATION ADMINISTRATION. NEITHER LUMEN DRAWING SO TPA ORDERED. CAP AND LINES CHANGED TO REPLACE CRACKED CAP. A SAMPLE WAS REQUESTED TO BE RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. 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
TRANSDUCER AND PRIMARY TUBING CONNECTED TO CAP WHEN FOUND TO BE CRACKED ALONG WITH MICROBORE TUBING AND A PALL FILTER CONNECTED FARTHER UP THE LINE FOR MEDICATION ADMINISTRATION.