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MalfunctionOFF

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

Catalog 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.