MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 3FX60CM SGL VASCU-LINE W/CUFF

Model Number	MR28013151
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.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
A (b)(6) patient dependent on tpn.At the end of perfusion, the mother irrigated the catheter with a saline solution.The catheter was leaking at the junction of the base of the white hub and the extension.Patient could not receive his parenteral nutrition (of the day).Fasting for less than 24 hours.The mother was instructed to clamp the catheter between the insertion site and the leak.Apply dressing to protect.Do not use catheter until replaced.Put on emergency list for replacement under general anesthesia.Piv inserted next am by dr.
Additional Manufacturer Narrative
The cvc was returned for evaluation.Visual inspection confirms the complaint as a leak is noted at the luer/extension joint.The lumen was clamped and the device flushed with water.Water was noted coming from "inside" the luer/extension joint.The device was forwarded to medcomp engineering for further evaluation.Under magnification it could be seen that the extension tubing partially delaminated from the isoplast luer.This occurs when forces that exceed the tensile strength of the tubing, causing the tubing to detach from the adhesive and resulting in a tear.This can happen from bending, twisting, cleaning of the tubing, or excessive force used to remove an end cap.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specifications with no non-conformances or abnormalities.The process includes a 100% leak test performed at the very end of the manufacture process.This test would have detected a hole or weak spot if it had existed at the time of manufacture.A definitive root cause could not be determined.The device was implanted for approximately 16 weeks prior to the incident.It appears that the section of the catheter may have been exposed to forces beyond the design capabilities.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: 3FX60CM SGL VASCU-LINE W/CUFF
• Common Device Name: VASCU-LINE
• 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: 13500361
• Report Number: 2518902-2022-00018
• Device Sequence Number: 19812114
• Product Code: LJS
• UDI-Device Identifier: 00884908094862
• UDI-Public: 884908094862
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/14/2022

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: 02/06/2024
• Device Model Number: MR28013151
• Device Catalogue Number: MR28013151
• Device Lot Number: MPLD460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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 Age: 10 YR
• Patient Sex: Unknown