MAUDE Adverse Event Report: MEDCOMP 13.5FX20CM SIL DBL LMN W/STYLET; HEMO-CATH ST HEMODIALYSIS CATHETER

Model Number SDL138E.

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Received a 13.5f hemo cath for evaluation.A visual inspection reveals a pinhole in the venous extension tubing.The device was forwarded to the device contract manufacturer for evaluation.

Event Description

A blood leak on the venous branch of the catheter was noticed after insertion.The dressing was full of blood.The blood was not coming from the puncture site but trickling from a hole, noticed under the blue clamp.

• Brand Name: 13.5FX20CM SIL DBL LMN W/STYLET
• Type of Device: HEMO-CATH ST HEMODIALYSIS CATHETER
• 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: 7619707
• MDR Text Key: 112446849
• Report Number: 2518902-2018-00038
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908042368
• UDI-Public: 884908042368
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

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
• Device Operator: Other
• Device Expiration Date: 12/31/2019
• Device Model Number: SDL138E.
• Device Catalogue Number: SDL138E.
• Device Lot Number: MGNV030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2014
• 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