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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 19/36 PALINDROME P KIT X5; DIALYSIS CATHETER

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COVIDIEN 19/36 PALINDROME P KIT X5; DIALYSIS CATHETER Back to Search Results
Model Number 8888145014P
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2016
Event Type  malfunction  
Manufacturer Narrative
Submit date: (b)(6) 2016.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 alleges that a palindrome catheter inserted at this hospital has a hole in it.
 
Manufacturer Narrative
A device history record review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The product sample was returned for investigation, it consisted in a palindrome catheter, product id 8888145014p, that showed signs of used (blood residues).Functional test was performed in order to confirm the defect reported by the customer, after the test the catheter showed a leakage in the venous extension.Visual inspection of the sample revealed an irregular pin hole in the silicone tubing.Sample was received damaged after being manipulated by the customer, this manipulation could be associated to the damaged found in the extension; therefore it can be concluded that this defect could be related to the use of sharp objects or rough edges after or during catheter insertion.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time.Moreover, 100% devices are inspected for leaks or cuts in the extensions; therefore the most probable root cause can be considered as misuse; this defect was more likely damaged during use caused due to the inappropriate use of sharp objects, repeated clamping or other similar damage.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection, leak testing and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% leak testing at the final stage of production, which would identify this issue in the catheter assembly.No additional actions are required.This complaint will be used for tracking and trending purposes.
 
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Brand Name
19/36 PALINDROME P 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 manufacturing solulfons sa
edificio 820 calle #2 zona franca coyol
alajuela
CS  
Manufacturer Contact
thom mcnamara
15 hampshire st.
mansfield, MA 02048
5084524811
MDR Report Key5563531
MDR Text Key42895236
Report Number3009211636-2016-00153
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/31/2016
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 Number8888145014P
Device Catalogue Number8888145014P
Device Lot Number1521000157
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/31/2016
Initial Date FDA Received04/08/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/19/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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