MAUDE Adverse Event Report: MEDCOMP 10F X 18CM SPLIT CATH XL; SPLIT CATH XL HEMODIALYSIS CATHETER

Model Number ASPC18P-XL

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 01/27/2018

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.Currently waiting for additional information.

Event Description

Accidental disconnection of arterial line.Blood loss <20cc.

Manufacturer Narrative

The device involved in the incident was not removed and remains implanted in the patient and in use.No evaluation of the device can be performed.The device was implanted for 8 months prior to the incident.No reports of a similar incident with this device have been received.Attempts to obtain additional information regarding the incident were unsuccessful.The female luers are manufactured to meet the iso standard (iso 594-2:1998).They are universal female luers and will mate with any universal male luer of the bloodlines, syringes, injection caps, etc.If they are also manufactured to the iso standard.Without an evaluation of the device the investigation cannot determine if the failure was related to manufacturing.It is unlikely due to the device having been in use and continues to be used with no reported problems.It is possible the connection to the blood line was not fully secured at the onset of the hemodialysis treatment.

• Brand Name: 10F X 18CM SPLIT CATH XL
• Type of Device: SPLIT CATH XL HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7660390
• MDR Text Key: 113299565
• Report Number: 2518902-2018-00041
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908003437
• UDI-Public: 884908003437
• Combination Product (y/n): N
• PMA/PMN Number: K020936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

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
• Device Operator: Other
• Device Expiration Date: 10/30/2018
• Device Model Number: ASPC18P-XL
• Device Catalogue Number: ASPC18P-XL
• Device Lot Number: MHJJ150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 05/07/2019
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOOD TUBING
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 14