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

Model Number MFFS1515IJ

Device Problem Break (1069)

Patient Problem Air Embolism (1697)

Event Date 08/29/2023

Event Type  Death  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 323201965
• Report Number: 2518902-2023-00060
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00884908030464
• UDI-Public: 00884908030464
• Combination Product (y/n): N
• Reporter Country Code: NP
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• 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): Death