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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSTA RICA PALINDROME 19/36 KIT W/ SLOT; DIALYSIS CATHETER

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COSTA RICA PALINDROME 19/36 KIT W/ SLOT; DIALYSIS CATHETER Back to Search Results
Model Number 8888145014
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2014
Event Type  malfunction  
Event Description
It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter.The customer states that cuff separated from the catheter.After 8 months, the catheter fell out of the patient's body.The product was tested prior to use.The catheter was replaced with a new one.No report of infection.
 
Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
 
Manufacturer Narrative
Product sample was not returned for evaluation, but a photo was provided by the customer.The image shows the catheter tubing with its cuff missing.The remaining glue and some cuff felt can be seen on the catheter.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter if it appears damaged or defective.The catheter tubing can tear when subjected to excessive force or rough edges.Do not use a sharp, jerking motion or undue force; this may tear the catheter.It is important to free the cuff and surfaces from the tissue prior to removal.The photo given by the customer provides evidence to confirm the issue.The image sample shows evidence of cuff adherence as it presents felt filaments and glue residue in a very observable level.The event description stated that the catheter was tested prior to use and additionally functioned as intended for eight (8) months, therefore it can be concluded that the device was more likely damaged during use.The product sample was not returned to the manufacturing site for review.With the available information, the most probable root cause would be due to excessive force or a jerking motion.However without further information, this cannot be confirmed.The device history record (dhr) review was performed.The dhr review indicated that there were no quality issues associated with this reported condition.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.As per procedure, manufacturing performs 100% visual and dimensional inspection and 100% assembly final inspection respectively, which would identify cuff defects in the catheter assembly.This complaint will be used for tracking and trending purposes.
 
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Brand Name
PALINDROME 19/36 KIT W/ SLOT
Type of Device
DIALYSIS CATHETER
Manufacturer (Section D)
COSTA RICA
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 Key4221154
MDR Text Key4970890
Report Number3009211636-2014-00140
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 Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/25/2014
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 Number8888145014
Device Catalogue Number8888145014
Device Lot Number212420X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/01/2015
Initial Date FDA Received11/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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