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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 8813793009
Device Problem Detachment Of Device Component (1104)
Patient Problem Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
No lot number was identified, therefore a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed. However, all dhrs are reviewed for accuracy prior to product release. Five photos were provided by the customer. Visual evaluation of these photos was performed. Three of the pictures showed both extension tubes (arterial and venous) of the catheter disconnected from the y-connector. Another photo revealed a catheter inside the patient, near the neck, without extensions in the hub. The last photo shown tubing with a clamp. Additionally, one used dual catheter was received for analysis and investigation. Visual inspection of the sample revealed that the both extension tubes (arterial and venous) of the catheter disconnected from the y-connector and the catheter presented signs of use. Dimensional evaluation was required. After the dimensional testing was completed, it was identified that all dimensions are within specification. An ishikawa diagram was used to determine the potential causes for this event. Manufacturing performs 100% visual inspection, in process inspection, and leak testing per procedure. A leakage would be detected during these processes. According to the instructions for use (ifu) the customer must perform an inspection before using the device. The ifu states to not use the catheter if it is crushed, cracked, cut, or otherwise damaged and not to infuse against a closed clamp or forcibly infuse a blocked catheter because back pressure could force the adapter to loosen and potentially come out of the tubing. Multiple components are used in the manufacture of this product. Components properties are tested by the suppliers and there are controls in place in the manufacturing site to prevent non-conforming material to be used. The reported condition has been confirmed. With the information provided there is no evidence to relate this event to the manufacturing process. The catheter functioned as intended for an undetermined time without problems. According to the event description, the pictures provided, and the event replication, the most possible cause for this event is ifu were not followed causing detachment of the adapter. No triggers or trends were identified. This complaint related to harm in the patient, however the severity calculate d was found lower than the expected in the risk assessment. Therefore, a corrective and preventive action (capa) is not 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 incident sample has been requested but to date has not been received for evaluation. If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted. 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
According to the reporter, during dialysis treatment, both catheters were disconnected from the y-connector and caused a leak, however there was no alarm given by the machine. During the incident there was significant loss of blood noted.
 
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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
diane mahteus
15 hampshire street
mansfield, MA 02048
5085421480
MDR Report Key6905111
MDR Text Key109558167
Report Number3009211636-2017-05312
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813793009
Device Catalogue Number8813793009
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2017
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 Unkown

Patient Treatment Data
Date Received: 09/29/2017 Patient Sequence Number: 1
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