MAUDE Adverse Event Report: MEDCOMP 14F X 24CM SPLIT CATH III

Model Number ASPC24-3E.

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved was discarded by the facility and not returned for evaluation.Photographs were provided.The photograph revealed a slice in the lumen.The slice was reported to have been under the gauze dressing.The ballooning occurred after the lumen was clamped to prevent blood loss through the slice.As the device was implanted for approximately one year, the root cause of ballooning is most likely not due to a manufacture issue.Without an evaluation of the actual device, a definitive root cause cannot be determined.

Event Description

After being implanted for approximately 12 months, the lumen of the catheter was noted to balloon.A slice/cut appears on a portion of the lumen which was under a gauze dressing.The ballooning was reported to occur after the catheter was clamped to block the blood from leaking out from the slice.The catheter was used only for dialysis and was not used for power injections.Catheter was removed.

• Brand Name: 14F X 24CM SPLIT CATH III
• Type of Device: SPLIT CATH III
• 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: 8921139
• MDR Text Key: 155399108
• Report Number: 2518902-2019-00056
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908003512
• UDI-Public: 884908003512
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K040318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: ASPC24-3E.
• Device Catalogue Number: ASPC24-3E.
• Device Lot Number: MLCP800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 45