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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP 12.5FX18CM LT HEMO-CATH; HEMO-CATH HEMODIALYSIS CATHETER
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MEDCOMP 12.5FX18CM LT HEMO-CATH; HEMO-CATH HEMODIALYSIS CATHETER Back to Search Results
Model Number MC101242
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 11/01/2018
Event Type  malfunction  
Event Description
Catheter initially placed a few days prior.Patient received hemodialysis without incident.Arrived for hemodialysis treatment this am and rn noticed "leaking blood" when performing initiation for treatment protocol.Re-examined lines and connections and noticed pin-hole in both lumens.
 
Manufacturer Narrative
Attempts to obtain additional information and the sample for evaluation were unsuccessful.A record review of the involved lot has been requested from the contract manufacturing facility.No further investigation is possible at this time.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.
 
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Brand Name
12.5FX18CM LT HEMO-CATH
Type of Device
HEMO-CATH HEMODIALYSIS CATHETER
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
MDR Report Key8132819
MDR Text Key129610229
Report Number2518902-2018-00064
Device Sequence Number1
Product Code MSD
UDI-Device Identifier88490802999
UDI-Public88490802999
Combination Product (y/n)N
PMA/PMN Number
K113487
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2023
Device Model NumberMC101242
Device Catalogue NumberMC101242
Device Lot NumberMKBY890
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/07/2018
Event Location Outpatient Treatment Facility
Date Manufacturer Received11/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age10 YR
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