MAUDE Adverse Event Report: COVIDIEN PALINDROME 28/45 SPORT W/ SLOT; DIALYSIS CATHETER

Model Number 8888128450

Device Problem Hole In Material (1293)

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

Event Date 06/19/2015

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 reports that this catheter was removed from a patient due to a pinhole in the venous lumen of the catheter.After removal another pinhole was detected in the arterial lumen.The catheter was replaced.The catheter was originally installed on (b)(6) 2015.

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample and three photos were received for evaluation.A visual inspection of the tubing revealed a pinhole on the venous lumen of the catheter.The photos were inspected and one fissure on the extension tube was found as well as a pinhole on the extension tube.The sample was submitted to an underwater test.Bubbles came from the catheter during the test.Per instructions of use, clamping the catheter repeatedly in the same spot could weaken the tubing.In order to avoid damage on the silicone tubing, the user must change the position of the clamp regularly to prolong the life of the tubing.In addition, it is also recommended to avoid clamping near the adapter and hub.Exercise caution when using sharp instruments near the catheter.Catheter tubing can tear when subjected to nicks, excessive force or rough edges.The most possible root cause can be due to the catheter being punctured with a sharp object.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 non-conforming product from leaving the manufacturing operations.A corrective action is not required at this time.As per procedure, manufacturing performs 100% visual inspection during production, which would identify problems on adapters in the catheter assembly.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

The product id has been identified as 8888128450, palindrome 28/45 sport w/ slot.

• Brand Name: PALINDROME 28/45 SPORT W/ SLOT
• 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 ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4879664
• MDR Text Key: 17693710
• Report Number: 3009211636-2015-00291
• 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,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2015

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: 8888128450
• Device Catalogue Number: 8888128450
• Device Lot Number: 301740X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 06/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/13/2015; 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1