MAUDE Adverse Event Report: MEDCOMP 8F X 18CM HEMO-CATH; HEMO-CATH LT

Model Number SL18P

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information regarding the event and the device were requested, but not provided.If the information becomes available the incident will be further evaluated and an supplemental report will be submitted.

Event Description

Hole in lumen.

• Brand Name: 8F X 18CM HEMO-CATH
• Type of Device: HEMO-CATH LT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 8887874
• MDR Text Key: 204049093
• Report Number: 2518902-2019-00052
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K893439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MCFJ570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 11