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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 8813817009
Device Problem Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2017
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 defective and there was leak near the adapters. Patient status was asked but unknown.
 
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. Sample consisted in one duals catheter used came inside a generic plastic bag. Visual evaluation of the sample reveals signs of use. Underwater test was performed and leak was identified in the catheter. Pinhole was observed on tubing. 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 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. The evidence provided is enough to discard the manufacturing process as a potential cause. 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.
 
Manufacturer Narrative
The date that the manufacturer was initially made aware of the reportable information for this complaint issue was march 13, 2018. 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
jacqueline st. pierre
15 hampshire street
mansfield, MA 02048
5084524938
MDR Report Key7341675
MDR Text Key102583737
Report Number3009211636-2018-00073
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
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 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2020
Device Model Number8813817009
Device Catalogue Number8813817009
Device Lot Number1533200072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2015
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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