MAUDE Adverse Event Report: MEDCOMP 12.5F X 15CM HEMO-CATH

Model Number	MC101241
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information regarding the incident has been requested.
Event or Problem Description
Hole in line.
Additional Manufacturer Narrative
Attempts to obtain additional information were unsuccessful.

• Brand Name: 12.5F X 15CM HEMO-CATH
• Common Device Name: HEMO-CATH
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8859230
• Report Number: 2518902-2019-00046
• Device Sequence Number: 18961414
• Product Code: MSD
• UDI-Device Identifier: 00884908082982
• UDI-Public: 884908082982
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2022
• Device Model Number: MC101241
• Device Catalogue Number: MC101241
• Device Lot Number: MKAA490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1