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

Model Number	ASPC18P-XL
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information.
Event or Problem Description
Accidental disconnection of arterial line.Blood loss <20cc.
Additional 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 1 year 18 days 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
• Common Device Name: SPLIT CATH XL HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7660518
• Report Number: 2518902-2018-00042
• Device Sequence Number: 1652588
• Product Code: MSD
• UDI-Device Identifier: 00884908003437
• UDI-Public: 884908003437
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K020936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 11/27/2017
• Device Model Number: ASPC18P-XL
• Device Catalogue Number: ASPC18P-XL
• Device Lot Number: MGTV070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 05/07/2019
• 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
• Patient Age: 5 YR
• Patient Weight: 19