MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 14F X 32CM SPLIT CATH III

Model Number	ASPC32-3E.
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is ongoing.Additional information regarding the incident has been requested.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
When disconnecting the catheter, after to unscrew the line, the venous line has been "sectioned".
Additional Manufacturer Narrative
No device was returned for evaluation, no photographs provided.Multiple requests for clarification of event were not successful.The contract manufacturer conducted a review of the manufacture records for the lot number reported.There were no amvs (authorized manufacturer variance) or ncrs (non-conformance report) associated with the involved lot related to the failure mode.The device history record review indicated the catheter was manufactured according to standard operating procedures, qa procedures, and customer drawing specifications.Without the requested clarification of event it is not known what the issue is or what may have caused it.No further investigation is possible, a root cause cannot be determined.

• Brand Name: 14F X 32CM SPLIT CATH III
• Common Device Name: SPLIT CATH III
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 14052177
• Report Number: 2518902-2022-00025
• Device Sequence Number: 4925389
• Product Code: MSD
• UDI-Device Identifier: 00884908003895
• UDI-Public: 884908003895
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/19/2025
• Device Model Number: ASPC32-3E.
• Device Catalogue Number: ASPC32-3E.
• Device Lot Number: MPKG550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown