MAUDE Adverse Event Report: COVIDIEN ***TENCKHOFF CATH 42CM 2 CUFF; DIALYSIS CATHETER

Model Number 8810888003

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer stated that there had been several incidents where there had been a small hole in the catheter at the end of the tip of the adaptor.They were quite sure that the holes were made from the adaptors.This is all the information that is available, the customer was unsure of how long the issue occurred.

Manufacturer Narrative

The complaint sample was not returned to the manufacturing site for review.The manufacturing lot number associated with this complaint was not provided.Without the lot number, a device history record (dhr) review could not be performed.All dhrs are reviewed for accuracy prior to product release.Since the sample was not returned, there is not enough evidence to determine what could cause this event.Should the sample be returned in the future, this complaint will be re-opened for further investigation.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.

• 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: 5357017
• MDR Text Key: 35970655
• Report Number: 3009211636-2016-00029
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8810888003
• Device Catalogue Number: 8810888003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2016
• 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