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U.S. Department of Health and Human Services

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

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COVIDIEN 36CM PERM CATH KIT X5; DIALYSIS CATHETER Back to Search Results
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.
 
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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 Key5380432
MDR Text Key36929001
Report Number3009211636-2016-00040
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
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 Number8817748001
Device Catalogue Number8817748001
Device Lot Number209607X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/13/2016
Initial Date FDA Received01/20/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/29/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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