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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. DUAL CATH, METHODE B. CANAUD; CANAUD HEMODIALYSIS CATHETER
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MEDICAL COMPONENTS, INC. DUAL CATH, METHODE B. CANAUD; CANAUD HEMODIALYSIS CATHETER Back to Search Results
Model Number MCCC1040K-A
Device Problem Disconnection (1171)
Patient Problem Blood Loss (2597)
Event Date 12/31/2019
Event Type  malfunction  
Manufacturer Narrative
Currently waiting for the return of the device sample for evaluation.
 
Event Description
Blood was noted to be leaking from the exit site.The venous adapter was reported to have detached from the lumen.
 
Manufacturer Narrative
Device was not returned for evaluation.Photographs of the device were requested but not received.Lot number was not provided.Attempts to obtain this information were unsuccessful.Without an evaluation of the device or detailed photographs of the issue, a root cause cannot be determined.Without a lot number a record review cannot be conducted.If the device should become available for evaluation the complaint will be reopened and investigated.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
DUAL CATH, METHODE B. CANAUD
Type of Device
CANAUD HEMODIALYSIS CATHETER
Manufacturer (Section D)
MEDICAL COMPONENTS, INC.
1499 delp drive
harleysville PA 19438
MDR Report Key9741008
MDR Text Key195752686
Report Number2518902-2020-00010
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00884908025972
UDI-Public884908025972
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMCCC1040K-A
Device Catalogue NumberMCCC1040K-A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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