MAUDE Adverse Event Report: COVIDIEN 36CM PERM CATH KIT X5; DIALYSIS CATHETER

Model Number 8817748001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer stated that there was errhysis (slow bleed) in the joint of the catheter when conducting dialysis, therefore dialysis failed.There was no patient injury.

Manufacturer Narrative

Submit date: 06/03/2015 an investigation is currently under way; upon completion the results will be forwarded.Multiple attempts have been made for additional clarification on the incident reported.If additional pertinent information becomes available, the report will be updated.

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There were no non-conformances related to the reported issue.No trends or triggers were identified.The product sample consisted of one incomplete kit of product 36cm perm cath kit x5.The incomplete kit came inside a plastic bag and it presented signs of use.The kit was open and contained a catheter and sheath/dilator, oval.Visual inspection was performed and did not present any issue with the components of the kit that was returned.The returned sample was submitted to an underwater test.Both lumens (arterial and venous) extensions did not show bubbles during the test.Manufacturing performs 100% visual inspection per procedure and 100% leak testing per procedure; therefore a leakage would be detected during these processes.The device was returned and evaluated and no issues were found during visual inspection and functional testing.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter if it appears damaged or defective.The catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks scrapes, and cuts which could impair its performance.Do not use acetone on any part of the catheter.A leak could be caused due to excessive force, sharp objects or due to an inappropriate use of cleaning agents.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.This complaint will be used for tracking and trending purposes.

• Brand Name: 36CM PERM CATH KIT X5
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4814967
• MDR Text Key: 5833478
• Report Number: 3009211636-2015-00253
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 208214X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1