MAUDE Adverse Event Report: COVIDIEN DIALYSIS UNKNOWN; DIALYSIS CATHETER

Model Number UNK DY

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter.The customer reports that during a dialysis the palindrome device came out with few cm, the distal tip might not be in the atrium.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There are no non-conformances related to the reported issue.The product sample returned consisted of one 14.5 fr tal palindrome with slots catheter, 28 cm implant length, 45 cm overall length.The catheter presented signs of use.A visual inspection was performed and a piece of tape was found around the felt cuff, which was properly placed.There were no issues found on the catheter or the cuff.The cuff presented appropriate felt filaments and glue residue.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.Do not use a sharp, jerking motion or undue force; this may tear the catheter.Free the cuff and surfaces from the tissue prior to removal.The reported issue could not be confirmed.The most probable root cause could be due to the placement method used.Catheter migration can be due to excessive force or due to a jerking motion.A corrective action is not applicable 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.As per procedure, manufacturing performs 100% visual and dimensional inspection and 100% assembly final inspection respectively, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: DIALYSIS UNKNOWN
• 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: 4359419
• MDR Text Key: 5111724
• Report Number: 3009211636-2014-00207
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK DY
• Device Catalogue Number: UNK DY
• Device Lot Number: 119856
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1