MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 10F X 24CM SPLIT CATH; SPLIT CATH XL

Model Number	ASPC24P-XL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is ongoing.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
Extension tubing torn at the hub.
Additional Manufacturer Narrative
No device was returned.Photographs and a video were provided by the end user.On the video it can be appreciate that the extension tubing extension separated from the hub area.The complaint was confirmed.A supplier corrective action request was issued to the contract manufacturer.The contract manufacturer's investigation revealed that the reported failure mode could be the result of improperly inserting the extension tubing into the molding machine during the hub molding process.Actions have been taken to update the procedures to minimize this type of occurrence.All personnel involved in this process have been trained to the changes made.Based on historic data this is not a systemic issue and is considered an isolated incident.This type of event will be trended through the complaint handling process.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.

• Brand Name: 10F X 24CM SPLIT CATH
• Common Device Name: SPLIT CATH XL
• 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: 15657567
• Report Number: 2518902-2022-00064
• Device Sequence Number: 20448939
• Product Code: MSD
• UDI-Device Identifier: 00884908003581
• UDI-Public: 884908003581
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/10/2023

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: 06/07/2024
• Device Model Number: ASPC24P-XL
• Device Catalogue Number: ASPC24P-XL
• Device Lot Number: MQBB240
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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