MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE NEURO INTERVENTIONAL PACK (NITAE)809 NEUROLOGICAL TRAY

Model Number SNE73NITA6

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record for lot number 20200525-23-sh revealed the product was manufactured on may 31st 2020. Based on supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident. The average linting data is 0. 143g / 10pieces. No sample was returned for investigation, only photos were provided. No obvious abnormal lint was found on the surface of the product; however, there are neps on the surface of the towel. According to the supplier, or towel is made of cotton, so cotton fiber is born. The supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process. The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement. C. Linting test method and acceptable criteria was stipulated to see the suction results. (
=
0. 38g/10pieces). In the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer. The investigation revealed no abnormal situation happened in production; therefore, the root cause could not be determined. The complaint information was shared with the relevant sectors for their awareness. No action will be taken at this time, but the supplier will continue to monitor the trends for this type of incident.

Event Description

Customer reported excessive linting of blue cotton towel in the pack found during cerebral angiogram with intervention. There was no injury or adverse effect due to excessive lint.

• Brand Name: NEURO INTERVENTIONAL PACK (NITAE)809
• Type of Device: NEUROLOGICAL TRAY
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085
• MDR Report Key: 10899856
• Report Number: 1423537-2020-00568
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10888439877175
• UDI-Public: 10888439877175
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SNE73NITA6
• Device Catalogue Number: SNE73NITA6
• Device Lot Number: 474827
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Age: 75 YR