MAUDE Adverse Event Report: COVIDIEN UVC TRAY/NO CATHETER; CATHETER, UMBILICAL ARTERY

Model Number 8888160408

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported the stopcocks on the umbilical lines are cracking.There was no harm to the patient.

Manufacturer Narrative

Since a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One used 3-way stopcock was received for the evaluation.Upon visual inspection and testing of the sample, crack was detected, in addition drag marks were observed at the crack indicating possible excessive force applied during use.The manufacturing site has intended to replica the issue with three different 3-way stopcocks.Different caps were placed generating an over thread on the female port and after removing the caps the female port showed marks like those of the received samples.An ishikawa diagram was used to determine the root cause of the reported issue.Through visual evaluation it was observed that the 3-way stopcock was cracked at one female port.Due to the appearance of the 3-way stopcock received, it is possible that the 3-way stopcock was damaged during clinical use, resulting in a stopcock cracking.Additionally, the 3-way stopcock was in use for an undetermined amount of time without issues, which implies that the issue occurred after customer manipulation.It is important to consider that the instructions for use warning [if infusing lipid containing solutions, monitor stopcocks for leakage.Lipids may cause cracking of plastic stopcocks].Therefore, the most probable root cause can be considered as misuse; this issue could have happened more likely due to damage during use caused by an inappropriate manipulation by the user.Therefore, a corrective action is not applicable at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: UVC TRAY/NO CATHETER
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 10390884
• MDR Text Key: 202391196
• Report Number: 3009211636-2020-00711
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 10884527005147
• UDI-Public: 10884527005147
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160408
• Device Catalogue Number: 8888160408
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/17/2020
• Patient Sequence Number: 1