MAUDE Adverse Event Report: COVIDIEN 36CM PERM CATH KIT X5; DIALYSIS CATHETER

Model Number 8817748001

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

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

Event Date 01/12/2016

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 reports the device has been used for approximately half a month.The blood flow was not smooth, there were three holes found on the lower 1 cm of the cuff after removing the device.

Manufacturer Narrative

(b)(4).As part of the investigation process, the finished good lot was reviewed.The device history record (dhr) review does not reveal any deviation of the current procedure that might have contributed to the reported condition.In addition, no nonconformance reports (ncrs) were opened for all the assembly levels, raw materials and incoming components.No changes to product manufacturing have been reported in the six months prior to its manufacture.One permcath catheter was received for analysis and investigation.Functional test was performed in order to confirm the reported condition and as a result a leak was identified in the shaft of the catheter.Visual inspection of the sample revealed a cut in the tubing approximately 1cm below the cuff.The following potential causes were identified: material: no potential causes were identified under material category.Dhr was reviewed and no deviations related to this failure mode were found.Manpower.Operator failed to follow procedures: manufacturing performed 100% visual inspection and 100% pressure test.The history record review for the lot number reported does not reveal any deviation of the current procedure that might have contributed to the reported condition.(discarded).Customer misuse: sample was received damaged after being in use for a period of 15 days approximately, during this time the catheter did not present problems and the issue was not identified prior to use.As per the instructions for use (ifu), catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks scrapes, cuts, etc., 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 manufacturer instructions for use.Based on the available information this potential root cause could not be discarded.(not discarded).Equipment: equipment out of tolerance condition: the history record review for lot the number reported does not reveal any deviation of the current procedure that might have contributed to the reported condition.(discarded).Process/method: no potential causes were identified under process/method category.The dhr was reviewed and no deviations related to this failure mode were found.Environment: no potential causes were identified under environment category.The dhr was reviewed and no deviations related to this failure mode were found.This reported condition has been confirmed.Based on available information, the most probably root cause is product misuse.No trends or triggers have been found; therefore additional corrective or preventive actions are not required.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: 36CM PERM CATH KIT X5
• 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 manuf. solutions sa; edificio 820 calle#2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5380432
• MDR Text Key: 36929001
• Report Number: 3009211636-2016-00040
• 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: 01/13/2016

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: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 209607X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 01/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1