MAUDE Adverse Event Report: COVIDIEN PERMCATH 40CM; DIALYSIS CATHETER

Model Number 8817749001

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

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 5/06/2016 that a customer had an issue with a dialysis catheter.The customer reports a small hole was found at the tee junction (bifurcate) before implanting the device.

Manufacturer Narrative

A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs are reviewed for accuracy prior to product release.The product sample was received at the site for analysis and investigation, additionally one picture was provided by the customer.The sample consisted in one incomplete kit of the product permcath that came inside a generic plastic bag.The catheter and guide wire presented signs of use (the cuff was frayed and there was dirt in the surface of the guide wire).Visual evaluation of the catheter was performed and no defects were identified.The other tunneler and dilator that were returned with the catheter were found bent.Functional test (underwater test) was performed in order to confirm the reported defect; as a result no defective conditions were identified.The reported hole could not be confirmed.One photo was provided by the customer.Visual evaluation of this photo was performed; the picture showed a catheter in a relaxed position.In this image; a mark where the customer indicated the location of the hole was noted.The sample and the photo provided by the customer were evaluated and no defective conditions could be determined.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, or cuts which could impair its performance.Do not use acetone, alcohol, or any solution containing alcohol on any part of the catheter.Exposure to these agents may cause catheter damage.Aqueous-based povidone is recommended.Based on this information it is a probable cause that the clinician confused the catheter perforations during examination and considered this as a hole.With the available information this is the most possible root cause for this event.Based on the available evidence and dhr review it can be concluded that the product was manufactured according to specifications, and a cause could not be related to manufacturing activities at this point, the most probable root cause could be considered as customer perception.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: PERMCATH 40CM
• 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5684968
• MDR Text Key: 46778765
• Report Number: 3009211636-2016-00236
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

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: 8817749001
• Device Catalogue Number: 8817749001
• Device Lot Number: 230606X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 05/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1