MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15.5F X 15CM IJ ST CATH SET; ST FREE-FLOW IJ

Model Number	MFFS1515IJ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/29/2023
Type of Reportable Event	Death
Event or Problem Description
The patient passed away in the hospital.After autopsy, a large quantity of air has been located in the right ventricle and this is the probable cause of death.The dialysis catheter has been quarantined because the catheter could be the cause of the air embolism.After investigation, there seems to be a catheter defect.This type of defect abnormal and could be due to external factors.
Additional Manufacturer Narrative
An investigation has been initiated.Additional information and the return of the device has been requested.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.
Additional Manufacturer Narrative
The device was not returned to medcomp for evaluation due to the nature of the occurrence and the death of the patient.The facility maintains possession of the catheter for an internal investigation.Pictures of the device were provided and show a tear in the lumen close to the hub, at the tip of the lumen curve.The catheter was implanted for 54 days prior to the incident.A manufacturing record review of the possible catheter lots from the contract manufacturer was requested.The review verified that all parts were manufactured according to standard operating procedures, quality assurance procedures, and drawing specifications.A leak test is performed as the final manufacturing operation before inspection and packaging.Its purpose is to identify potential damage, such as holes, ruptures, tears, and small pinholes that could cause leaks in the catheter.Additional information provided by the facility: the patient has had an extensive trajectory within the hospital.We are unable to trace when and where the incident took place.The break was discovered after the autopsy.They emphasized that they filed this complaint for notification purposes.They are aware that the break occurred because of a department flaw.The instructions for use include the following precautions.Do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.Examine catheter lumen and extensions before and after each treatment for damage.Frequent visual inspections should be conducted to detect leaks to prevent blood loss or air embolism.

• Brand Name: 15.5F X 15CM IJ ST CATH SET
• Common Device Name: ST FREE-FLOW IJ
• 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: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 17730596
• Report Number: 2518902-2023-00060
• Device Sequence Number: 20374520
• Product Code: MPB
• UDI-Device Identifier: 00884908030464
• UDI-Public: 00884908030464
• Combination Product (Y/N): N
• Initial Reporter Country: NP
• 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): 09/21/2023

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 Model Number: MFFS1515IJ
• Device Catalogue Number: MFFS1515IJ
• Device Lot Number: MMKA760
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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: Death
• Patient Sex: Unknown