MAUDE Adverse Event Report: COVIDIEN PALINDROME 28/45 KIT W/ SLOT; DIALYSIS CATHETER

Model Number 8888145016

Device Problems Crack (1135); Mechanical Problem (1384); Use of Device Problem (1670); Noise, Audible (3273)

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

Event Date 05/26/2015

Event Type  malfunction  

Event Description

It was reported to covidien (b)(6), 2015 that a customer had an issue with a dialysis catheter.The customer reports the patient received a palindrome on (b)(6), 2013.On tuesday, (b)(6), 2015 the patient started dialysis according to the local routine.The dressing was clean and there was no concern with the exit site.The extensions are controlled and aspirated indwelling heparin from the catheter.Both extensions were flushed and aspirated.When preparing for dialysis, the tubes were linked inversely to the catheter arterial (red) adapter to the venous line and the blue adapter to the artery bloodline.After approximately 2 minutes an abnormal noise was noted coming from the dialysis machine.The sound was a crackling/slurping and became more intense.The tubing (bloodline), dialysis filter and the machine settings were reviewed.It was observed that the blood was pumping against the arterial side of the filter.When following the hoses, it could be seen that more and more air had filled the arterial blood line.The customer reported stopping the dialysis machine and inspecting the patient dialysis catheter.The dressing was a little bloody.The connections were checked to be certain they were secure.The hoses were disconnected and the dialysis catheter was inspected.It was discovered that there was a little crack in the dialysis catheter in the hose above the extension.A small crack was seen right at the entry in the y-split.The patient did not suffer as a result.On wednesday, (b)(6), 2015 the patient received a new dialysis catheter.The patient required medical intervention in order to place a new catheter.There have been no further problems and the current patient condition is good.

Manufacturer Narrative

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

Manufacturer Narrative

One sample was received for analysis and investigation.One used sample cut in three different portions was received; the first portion is from the catheter shaft and the tubing extensions (red and blue) were received cut from the catheters hub.Additionally, the sample presents signs for use (blood).Visual inspection revealed a little hole in the shaft just below the hub.The process failure mode and effect analysis per procedure was reviewed in order to identify potential causes associated with this event.The device history record (dhr) was also reviewed and no deviations related to this failure mode were found, all parameters were according to specification requirements.As per the instructions for use, the catheter product 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.While the labeling provides an appropriate warning, labeling cannot prevent a clinician¿s failure to heed the warning nor can labeling control use of appropriate measures to use a device according to the manufacturer instructions for use.As reported by the user, the catheter was implanted in (b)(6) 2013, for approximately 2 years the catheter performed as intended.This information rules out that the condition reported was caused during the product manufacturing, therefore product mishandling/misuse is considered a potential cause for this event.During product manufacturing, a chronic catheter pressure test is established so that all catheters must be submitted to an in-line occlusion and leak test per procedure.Manufacturing performs 100% leak testing during production, which would identify this issue in the catheter assembly.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: PALINDROME 28/45 KIT W/ SLOT
• 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: 4836217
• MDR Text Key: 5942126
• Report Number: 3009211636-2015-00268
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145016
• Device Catalogue Number: 8888145016
• Device Lot Number: 215951X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR