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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8831661001
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/28/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the catheter was found leaking from a crack on the arterial (red) silicone extension when the doctor was testing the flow during the insertion of the catheter. The catheter was removed and replaced with a new catheter. There was no patient injury reported.
 
Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted no abnormalities. Pmv performed functional testing which included submerging the catheter into a water bath. The end was clamped, and a syringe was used to inject air to observe leakage. No air bubbles were present. Both extensions were tested with acceptable results. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A device history review revealed no discrepancies that may have contributed to a complaint of this failure mode. All quality assurance testing performed during manufacturing was acceptable. The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements. All dhr are reviewed for accuracy prior to product release. The physical sample involved in the reported incident was not returned for evaluation. One photo was provided by the customer. Visual evaluation of this photo was performed and it revealed a cut in the arterial extension of the catheter. The catheter present sign of use (residues of blood). Manufacturing performs 100% leak testing as per procedure which would identify this issue in the catheter assembly. The reported condition has been confirmed. The physical sample involved in the reported incident was not returned for evaluation. Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time. 100% devices are inspected for leaks or cuts in the extensions. The most probable root cause can be considered as misuse; this defect was more likely damaged during use caused due to the use of strong cleaning agents, excessive force during of use, repeated clamping or other similar damage. No trends or triggers have been found. No action is deemed necessary at this time. It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameMAHURKAR
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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
lisa hernandez
15 hampshire street
mansfield, MA 02048
2034925563
MDR Report Key7397899
MDR Text Key104425623
Report Number3009211636-2018-00106
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/24/2021
Device Model Number8831661001
Device Catalogue Number8831661001
Device Lot Number1632900118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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