MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 14F X 28CM PC SPLIT CATH III

Model Number ASPC28-3PCE.

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.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

Uneventful dialysis until (b)(6) 2023.Patient attended unit and mentioned slight leak from around the line.On observations, the red lumen line directly above the white connection hub had a crack.

Manufacturer Narrative

One 14f x 28cm split cath was received for evaluation.A visual examination of the device reveals the red extension tubing is almost completely separated from the hub.Inside the hub, there is no evidence of extension material that would indicate the tubing tore.It appears the tubing pulled out of the hub.A supplier corrective action request was issued to the contract manufacturer for this event.The piece was evaluated dimensionally, visually, and cross sectionally.Visually there is no residue or damage in the affected area.Dimensionally the od and id of the extension are within specification.In the cross-section the lack of depth of the extension within the body of the catheter is observed.The device history record (dhr) review showed nothing out of specification, no authorized manufacture variance (amv), or non-conformance report (ncr) for the lot.Process review included the following operations- hub molding, leak test, and inspection.The investigation revealed the root cause is most likely failure to properly follow the procedures during the molding and inspection processes.As a result, the molding procedure was revised to include an audible alarm if the machine detects a rejection.All personnel involved in the molding and inspection processes were retrained to the procedures.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: 14F X 28CM PC 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: 18292356
• MDR Text Key: 330057386
• Report Number: 2518902-2023-00073
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ASPC28-3PCE.
• Device Catalogue Number: ASPC28-3PCE.
• Device Lot Number: MQFH780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 50 KG