CONNECTOR, BLOOD TUBING, INFUSION T
Received Aug 6, 2021 · Event occurred Jun 25, 2021
Report 3012307300-2021-08154 · MDR key 12290821
Device
Generic name
Connector, Blood Tubing, Infusion T
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED AFTER DEVICE EVALUATION. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. ONE FLAT FILTER AND EPIFUSE CONNECTOR AND FILTER COVER AND THE CATHETER WERE RETURNED. VISUAL INSPECTION RESULTS: AS A RESULT OF CHECKING THE SAMPLE, THERE WAS A CRACK IN THE FEMALE CONNECTOR OF THE FLAT FILTER, AND WHITENING WAS SEEN AT THE BASE OF THE FEMALE CONNECTOR. CONCLUSION: THE REPORTED EVENT WAS CONFIRMED. ROOT CAUSE: IT IS PROBABLE THAT THE CAUSE OF THIS EVENT WAS THAT A PHYSICAL LOAD WAS APPLIED TO THE FEMALE CONNECTOR AND A CRACK OCCURRED. HOWEVER, IT WAS NOT POSSIBLE TO IDENTIFY THE TIME WHEN THE PROBLEM OCCURRED, AND IT WAS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THE PROBLEM. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE CONNECTER WAS FOUND LEAKING AFTER ONE DAY OF INDWELLING. THERE WAS NO PATIENT HARM.