MAUDE Adverse Event Report: MEDCOMP 14F X 32CM SPLIT CATH III

Model Number	ASPC32-3E.
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for the device sample to be returned for evaluation.When the investigation is complete a final report will be submitted.
Event or Problem Description
Catheter was placed on (b)(6) 2019.The wing, allowing the catheter to be held by wires, was disconnected.The wing remained attached to the wires and the catheter came out.The catheter was torn off by the patient on (b)(6) 2019, after the catheter disconnected from the wing.
Additional Manufacturer Narrative
Attempts to obtain the sample were unsuccessful.Without an evaluation of the device involved we are unable to determine the exact cause of the event; however, it appears that at some point enough force was applied to the catheter to dislodge it from the suture wing.

• Brand Name: 14F X 32CM SPLIT CATH III
• Common Device Name: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8781790
• Report Number: 2518902-2019-00040
• Device Sequence Number: 19336448
• Product Code: MSD
• UDI-Device Identifier: 00884908003895
• UDI-Public: 884908003895
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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
• Operator of Device: Other
• Device Expiration Date: 07/02/2021
• Device Model Number: ASPC32-3E.
• Device Catalogue Number: ASPC32-3E.
• Device Lot Number: MHQZ420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 70