TENCKHOFF ACUTE PERITONEAL DIALYSIS CATHETER SET
Received Dec 16, 2018
Report 1820334-2018-03821 · MDR key 8167876
Product problems
- Fluid/Blood Leak
- Fitting Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE FIELD FOR SECTIONS WAS NOT POPULATED DUE TO A TECHNICAL LIMITATION: COMMON NAME: CATHETER, PERITONEAL; PRODUCT CODE: GBW.THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PERITONEAL DIALYSIS, A LUER LOCK CONNECTION ON TENCKHOFF ACUTE PERITONEAL DIALYSIS CATHETER WAS LEAKING WHEN CONNECTED O ANOTHER MANUFACTURER'S DIALYSIS BAG. THE LUER LOCK WAS NOT A "SNUG FIT" WITH THE OTHER MANUFACTURER'S KIT. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.