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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSTA RICA MAXID 23/48 KIT W/OUT SIDEHOL; DIALYSIS CATHETER

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COSTA RICA MAXID 23/48 KIT W/OUT SIDEHOL; DIALYSIS CATHETER Back to Search Results
Model Number 8888145002
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2014
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 at post placement blood leakage was found from the hub during dialysis treatment.The catheter was placed for a month.The catheter was pulled and replaced with a new one on (b)(6) 2014.
 
Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
 
Manufacturer Narrative
The product sample returned was received within a generic plastic bag and consisted of one 14.5 fr dual lumen hemodialysis catheter with evidence of use.After visual inspection, no defects were identified.During underwater test (functional test) no bubbles were detected.Both lumens, arterial and venous did not show bubbles during the test.More information was requested to the customer and no additional evidence was provided for this analysis.This defect has not been confirmed.With the available information, the most probable root cause for this kind of leak (if the device had been found defective) could be considered as misuse due to over bending or excessive force.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.Per procedure, manufacturing performs 100% leak testing at the final stage of 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
MAXID 23/48 KIT W/OUT SIDEHOL
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
edificio 820 calle #2 zona franca coyol
edificio 820 calle #2 zona franca coyol
alajuela
CS  
Manufacturer Contact
lawrence rock
15 hampshire street
mansfield, MA 02048
5082616625
MDR Report Key4220839
MDR Text Key21527259
Report Number3009211636-2014-00138
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/13/2014
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 Number8888145002
Device Catalogue Number8888145002
Device Lot Number317164X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/24/2014
Initial Date FDA Received11/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/24/2014
Was Device Evaluated by Manufacturer? Yes
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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