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U.S. Department of Health and Human Services

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

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COVIDIEN PALINDROME 28/45 KIT W/ SLOT; DIALYSIS CATHETER Back to Search Results
Model Number 8888145016
Device Problem Hole In Material (1293)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 01/22/2016.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 states the palindrome chronic catheter was placed on (b)(6) 2016 in the patient where there was no leak at the time of placement.The patient dialyzed successfully after placement that same day.On (b)(6) 2016, the dialysis outpatient unit was noticed bleeding upon the patients arrival to the unit.The patient asked to visit the er at (b)(6) hospital where the patient was then taken to the ir department.The doctor exchanged the palindrome chronic catheter and noticed small pin holes in the catheter extension (red arterial side).
 
Manufacturer Narrative
The device history record (dhr) was reviewed and no deviations related to this condition were found.There are no non conformance reports (ncr)¿s related to the reported issue and lot.The product sample was returned for investigation; a palindrome catheter, clip and syringe were received inside a generic plastic that presented signs of use (remains of blood).A visual inspection was performed and pinholes were found on the arterial extension.In order to confirm the condition reported functional test was required.The returned sample was submitted to underwater testing and bubbles were detected coming from pinholes of the extension of catheter, from the lumen which corresponds to the arterial extension.The lumen related to the venous extension did not show bubbles during the test.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that the product was manufactured according to specifications and the device functioned as intended for the reported amount of time.Additionally, manufacturing performs a 100% visual inspection on catheter extensions and a 100% high pressure (leak) test.The product specification was reviewed in order to identify the possible root causes for the leaking.The most probable root cause could occur during use caused due to the use of sharp objects, repeated clamping or other similar damage as described in the instructions for use.Should the sample be returned in the future, this complaint will be re-opened for further investigation.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.Manufacturing performs a 100% leak test and a 100% visual inspection during production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.
 
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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 20101
CS   20101
Manufacturer Contact
thom mcnamara
15 hampshire street
mansfield, MA 02048
5084524811
MDR Report Key5385399
MDR Text Key36765622
Report Number3009211636-2016-00049
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 health professional,user faci
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/11/2016
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 Number8888145016
Device Catalogue Number8888145016
Device Lot Number1429700221
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/11/2016
Initial Date FDA Received01/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/28/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age54 YR
Patient Weight99
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