MAUDE Adverse Event Report: COVIDIEN PALIND 19/36 SLOT KIT W/VT; DIALYSIS CATHETER

Model Number 8888145039

Device Problems Air Leak (1008); Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a dialysis catheter.The customer reports that there was a leak on the catheter.It was leaking from the venous side but there were micro-bubbles in the circuit.There were 3 holes on the venous side and 3 holes on the arterial side around the clamp, in the middle.Catheter was removed and a new one was installed.No pt injury.The device is being returned for investigation.

Manufacturer Narrative

Submit date: (b)(4) 2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

All the possible causes were identified.The dhr was reviewed and no deviations related to this failure mode were found.There are no ncr's related to the reported issue.The sample was received.It consisted of a venous tubing silicone extension with its blue adult adapter and its clamp.Visual inspection was performed and no visual defects were found in the sample.However a video was attached to the complaint and leaking was confirmed from venous extension.The defect was confirmed.With the available information the most probable root cause can be related to misuse due to an inappropriate clamping.No additional actions are required.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.Per procedure, manufacturing performs 100% pressure tests.Qa performs in-process inspections at the final stage of production and which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: PALIND 19/36 SLOT KIT W/VT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer (Section G): COVIDIEN; edificio 820 calle #2 zona franca coyol; alajuela NY 12809 ; CS 12809
• Manufacturer Contact: lawrence rock ; 15 hampshire street; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 3906471
• MDR Text Key: 20653843
• Report Number: 1317749-2014-00260
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145039
• Device Catalogue Number: 8888145039
• Device Lot Number: 328330X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 06/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1