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 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information regarding the device and incident has been requested.

Event Description

Holes in the extension outside where the clamp is fixed.

Manufacturer Narrative

Based on the investigation performed and the inspection of the sample, it was concluded that the reported failure mode (holes in tubing) could have been caused by clamping the venous extension with the guidewire inside.The failure mode is considered not associated to the manufacturing processes.This family of devices has a 100% leak test as part of the manufacturing routine as a counter measure to detect this type of failure mode.

• Brand Name: 8F X 18CM HEMO-CATH
• Type of Device: HEMO-CATH LT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7601956
• MDR Text Key: 112145751
• Report Number: 2518902-2018-00036
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (y/n): N
• PMA/PMN Number: K893439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/22/2022
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MKAM100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 MO