MAUDE Adverse Event Report: MEDCOMP 14F X 28CM SPLIT CATH III; HEMODIALYSIS CATHETER

Model Number	ASPC28-3E.
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.Requests have been made for additional information and the return of the sample for evaluation if available.
Event or Problem Description
The connection between the venous blood line and the catheter connector separated 30 min before the end of the dialysis.The patient lost a lot of blood.
Additional Manufacturer Narrative
A review of the device history record was not possible as the lot number of the device was not provided.It was reported that the catheter remains implanted in the patient therefore could not be returned for evaluation.The catheter was implanted for 2 months with no other reported disconnections.Without an evaluation of the device we are unable to determine if there was a manufacturing issue with the catheter luer.It is possible the connection was not fully secured at the onset of the dialysis treatment or there was an issue with the fresenius bloodlines that caused/contributed to the disconnection.

• Brand Name: 14F X 28CM SPLIT CATH III
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7479773
• Report Number: 2518902-2018-00029
• Device Sequence Number: 1510410
• Product Code: MSD
• UDI-Device Identifier: 00884908003710
• UDI-Public: 884908003710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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?: No
• Operator of Device: Other
• Device Model Number: ASPC28-3E.
• Device Catalogue Number: ASPC28-3E.
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOOD TUBING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 59