MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 11F X 15CM DUO-FLOW IJ CATHETER

Model Number XTP116IJS=

Device Problem Unraveled Material (1664)

Patient Problems Respiratory Distress (2045); Shock (2072); No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2020

Event Type  Injury  

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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

When attempting to insert the guidewire into jugular catheter, at the beginning there was resistance but later on it enters, but the patient becomes shocked.More investigation showed vascular and pleural injury occurred.When removed the guidewire was kinked.The patient required intubation.

Event Description

During insertion the double lumen direct line, we insert the cath ij guidline and it?s stocked inside, after removing it the catheter came coiled extension mostly related to bad quality of the type of wire.

Manufacturer Narrative

Report submitted to correct b3-date of event, b5- description, d10-device availability, and h6-patient code.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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The guidewire was returned for evaluation but the catheter was not returned.Visual inspection of the guidewire confirms the allegation of kinks.Two kinks were noted, the first approximately 12.5 cm from the start of the "j" section and the second approximately 17 cm from the proximal end.Visual inspection of the returned device showed no signs of unraveling or stretching anywhere on the wire.The description states that the catheter "coiled" when the guidewire was removed.It cannot be determined if the issue was caused by the guidewire or the catheter.Without an evaluation of both the guidewire and catheter, the root cause cannot be determined.

• Brand Name: 11F X 15CM DUO-FLOW IJ CATHETER
• Type of Device: DUO-FLOW IJ
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10328535
• MDR Text Key: 200576661
• Report Number: 2518902-2020-00034
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908059267
• UDI-Public: 884908059267
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: XTP116IJS=
• Device Catalogue Number: XTP116IJS=
• Device Lot Number: MLLY680 S2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/20/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 65