MAUDE Adverse Event Report: COVIDIEN SWNNCK STR TNCKHFF CTR CUFF; DIALYSIS CATHETER

Model Number 8888422105

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on 05/12/2016 that a customer had an issue with a dialysis catheter.The customer states that a pin hole was found on the product and dialysate solution leaked during use.The product was used for one year.Leakage occurred for the first time.The catheter was cut by the hole.No patient harm.

Manufacturer Narrative

Submit date: 07/25/2016 as no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.Sample consisted of a pd catheter and presents signs of use.Visual inspection of the sample revealed a pin hole in the tubing of the catheter.Also, the sample return was attached to a baxter set and the catheter was cut approximately 2 cm below the titanium adapter.Three photos were provided by the customer.Visual evaluation of these photos was performed; the first picture showed two sections of a pd catheter attached to a titanium adapter.The second image shows a pin hole in one of the sections and a cut in the other section of the pd catheter.The last picture showed a pd catheter attached to a baxter set.In this image it was observed an unknown liquid around the pd catheter.An ishikawa diagram was used to determine the potential causes for this event.Possible root causes were identified.The reported condition has been confirmed.Based on sample evaluation and on the complaint description, the catheter functioned as intended for a period of one year.Based on the available information there is enough information to discard the manufacturing process.The most possible root cause could be related to customer misuse since the issue occurred after being in use for one year.Based on the sample provided, these kinds of holes/cuts could be caused by an improper use of sharp objects.No trends or triggers have been found, therefore, a corrective or preventive action is not deemed necessary at this time.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: SWNNCK STR TNCKHFF CTR CUFF
• 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 manuf. solutions sa; edificio 820 calle#2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: matthew amaral ; 15 hampshire st; mansfield, MA 02048 ; 2034926373
• MDR Report Key: 5676051
• MDR Text Key: 45812964
• Report Number: 3009211636-2016-00227
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

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: 8888422105
• Device Catalogue Number: 8888422105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1