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

Model Number ASPC32-3E.

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2022

Event Type  malfunction  

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 Description

When disconnecting the catheter, after to unscrew the line, the venous line has been "sectioned".

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
• Type of Device: 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
• MDR Text Key: 288865422
• Report Number: 2518902-2022-00025
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908003895
• UDI-Public: 884908003895
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention