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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN UNKNOWN DIALYSIS CATHETER

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COVIDIEN UNKNOWN DIALYSIS CATHETER Back to Search Results
Model Number UNKNOWN DY
Device Problems Hole In Material (1293); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2015
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) 2015 that a customer had an issue with a dialysis catheter.The customer reports that while flushing the dialysis catheter, a hole was discovered.The catheter was inserted (b)(6) 2015.The location of the hole is such that repair is not possible.
 
Manufacturer Narrative
Submit date: (b)(6) 2016.A device history record review could not be performed because the lot number provided is invalid.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.A corrective action is not required at this time.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 non-conforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% visual inspection during production, which would identify nicks or cuts in the catheter assembly.This complaint will be used for tracking and trending purposes.
 
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Brand Name
UNKNOWN DIALYSIS CATHETER
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 street
mansfield, MA 02048
5084524811
MDR Report Key5060462
MDR Text Key25791627
Report Number3009211636-2015-00358
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeCA
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 08/21/2015
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 NumberUNKNOWN DY
Device Catalogue NumberUNKNOWN DY
Device Lot Number15526598
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/21/2015
Initial Date FDA Received09/08/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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