MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. DUAL CATH, METHODE B. CANAUD; CANAUD HEMODIALYSIS CATHETER

Model Number MCCC1040K-A

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 12/10/2020

Event Type  Death  

Manufacturer Narrative

An investigation has been initiated.Additional information about the incident 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.

Event Description

At 10:15 am we were called by a nurse for an emergency.When we arrived we noticed a pool of blood (several liters) on the ground under the bed of miss (b)(6).The doctor who was already there was compressing the central venous catheter emergence points while the bio-medical technician on site began the cardiac massage.The patient was already not conscious.Call to (b)(6) at 10:20 am, which arrived at 10:45 am.The death was declared at 11:10 am.The (b)(6) doctor who established the death certificate declared the death suspicious, which led to the intervention of the judicial police as well as the scientific police at the request of the prosecutor.Photos were taken and staff questioned.The line as well as the branch of the central venous catheter still connected to the line were recovered by the judicial police.We could see that the guying wire was cut about 2cm from the attachment.The body left at 5:10 pm at the forensic unit.

Manufacturer Narrative

The device involved in the incident was not returned for evaluation, and no pictures of the device were provided.A record review of the catheter lots was requested of the device contract manufacturer.The record review of work orders for the possible catheter lots showed no nonconformities related to the reported failure mode and other abnormalities associated to the part number.There were no deviations or process changes in the manufacturing of this part number.All inspections and sequence of operations were properly followed and documented.Production and quality control followed specifications of the device drawing and instructions in the work orders.During dhr review nothing out of specification was found.A full review of the manufacturing processes was performed, nothing out of specification was found, everything was done according currently standard operation procedures, quality assurance procedure and customer drawing specifications; therefore, customer complaint is considered not related to the internal manufacturing processes.Without an evaluation of the device was are unable to determine the cause of the incident.The catheter was implanted for 4.5 months before the incident occurred with no reported problems.The report indicated the event occurred during a dialysis session and patient was sleeping and turned herself on the bed.It is possible the blood line or catheter line was subjected to sufficient force to tear the line when the patient turned.

• Brand Name: DUAL CATH, METHODE B. CANAUD
• Type of Device: CANAUD HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11300425
• MDR Text Key: 231115463
• Report Number: 2518902-2021-00006
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• 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
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MCCC1040K-A
• Device Catalogue Number: MCCC1040K-A
• Device Lot Number: MMDD280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 100