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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

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COVIDIEN MANUF. SOLUTIONS SA PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Model Number 8888541023P
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2017
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter.The customer states there is air passage on the arterial branch.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PALINDROME
Type of Device
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
COVIDIEN MANUF. SOLUTIONS SA
edificio 820 calle#2
zona franca coyol
alajuela 20101
Manufacturer (Section G)
COVIDIEN MANUF. SOLUTIONS SA
edificio 820 calle#2
zona franca coyol
alajuela 20101
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key6424343
MDR Text Key70561774
Report Number3009211636-2017-05041
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeFR
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 02/28/2017
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 Number8888541023P
Device Catalogue Number8888541023P
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/28/2017
Initial Date FDA Received03/22/2017
Supplement Dates Manufacturer Received02/28/2017
Supplement Dates FDA Received10/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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