MAUDE Adverse Event Report: COVIDIEN TENCKHOFF CATH (10); DIALYSIS CATHETER

Model Number 8888423103

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2015

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 (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer stated that the hospital found the tube was broken just after opening the box.The device was not used on the patient.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was release accomplishing all quality standards.Since the sample was not returned, there is not enough evidence to determine what could cause this event.However the pfmea was reviewed in order to identify the possible root causes for the failure hole in catheter.The following potential causes were identified in the pfmea or in addition to this document: machine malfunction, misuse, inspection in process failed or not performed, improper materials selected and/or sharps objects usage with catheter.With the available information it is not possible to confirm an exact root cause for this issue.Corrective actions were not required.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, in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.As per the procedure, manufacturing performs 100% visual inspection during production, which would identify nicks or cuts in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: TENCKHOFF CATH (10)
• 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 st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5117362
• MDR Text Key: 27586442
• Report Number: 3009211636-2015-00382
• 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
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/23/2015

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: 8888423103
• Device Catalogue Number: 8888423103
• Device Lot Number: 1428900115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1