TENCKHOFF SPIRAL CHRONIC PERITONEAL DIALYSIS CATHETER SET
Received Oct 25, 2017
Report 1820334-2017-03649 · MDR key 6976256
Product problems
- Occlusion Within Device
- Occlusion Within Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE TENCKHOFF SPIRAL CHRONIC PERITONEAL DIALYSIS CATHETER WOULD NOT FLUSH WITH FLUID. ANOTHER CATHETER WAS OPENED TO COMPLETE THE PROCEDURE, WITH NO FURTHER PRODUCT ISSUES REPORTED. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE NECESSITATED AND NO PATIENT ADVERSE EVENTS OCCURRED DUE TO THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED BUT COULD NOT BE PROVIDED BY THE REPORTER. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.
Additional Manufacturer Narrative
INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS NOT RETURNED, SO PHYSICAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, A REVIEW OF DOCUMENTATION WAS CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO OTHER NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER (7996497). ADDITIONALLY, A SEARCH OF THE MANUFACTURER'S COMPLAINT DATABASE FOUND ONE OTHER COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER (7996497). BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.