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

Model Number SL18P

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.

Event Description

Staff noticed blood leak and hole was noted on venous side of catheter just below hub.

Manufacturer Narrative

The contract manufacturer reviewed the device history record, sample and leak testing process.It was noted that the lot of catheters in question was 100% leak tested and that all catheters passed prior to release.It was determined that the failure occurred after being released from their facility.

• Brand Name: 8F X 18CM HEMO-CATH
• Type of Device: 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: 6560710
• MDR Text Key: 75150619
• Report Number: 2518902-2017-00020
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

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 Model Number: SL18P
• Device Catalogue Number: SL18P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/11/2017
• Supplement Dates Manufacturer Received: 04/14/2017
• Supplement Dates FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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: 2 YR