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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED
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COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Model Number 8888145014
Device Problem Hole In Material (1293)
Patient Problem Unspecified Infection (1930)
Event Date 12/02/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The customer states the patient experienced sepsis and was hospitalized and put on a course of antibiotics for a week.A crack was found on the venous extension and the catheter was immediately removed and later replaced.There were no complications for the patient since the replacement of the catheter.
 
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Brand Name
PALINDROME
Type of Device
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
Manufacturer Contact
jacqueline st. pierre
15 hampshire street
mansfield, MA 02048
5084524938
MDR Report Key7183641
MDR Text Key97014597
Report Number3009211636-2018-00015
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K111372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 01/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8888145014
Device Catalogue Number8888145014
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age50 YR
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