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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP 8F X 18CM HEMO-CATH; HEMO-CATH LT HEMODIALYSIS CATHETER
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MEDCOMP 8F X 18CM HEMO-CATH; HEMO-CATH LT HEMODIALYSIS CATHETER Back to Search Results
Model Number SL18P
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Blood Loss (2597)
Date of Event 10/03/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.
 
Event or Problem Description
Patient was receiving hemodialysis.Noted that machine was alarming and air had entered circuit.Crack in catheter between patient and hub noted with active bleeding.
 
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Brand Name
8F X 18CM HEMO-CATH
Common Device Name
HEMO-CATH LT HEMODIALYSIS CATHETER
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
MDR Report Key8111740
Report Number2518902-2018-00063
Device Sequence Number16204284
Product Code MSD
UDI-Device Identifier00884908045444
UDI-Public884908045444
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K893439
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source distributor,foreign,user faci
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/31/2020
Device Model NumberSL18P
Device Catalogue NumberSL18P
Device Lot NumberMBYP070
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/31/2018
Initial Report FDA Received Date11/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Weight10
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