MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE SDMC CRANIOTOMY PACK (CNKSN)254 NEUROLOGICAL TRAY

Model Number SNE59CNKSO

Device Problem Material Separation (1562)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Device history record could not be verified as lot number was not provided. There is no occurrence reported in the past 12 months. No sample was available for investigation. According to the supplier, the or towel is made of cotton, so lint is born and inevitable. The intended use of the or towel is used for applying medication or absorbing small amounts of body fluids from a patient's body surface. Supplier has worked with cardinal to better control the linting and has implemented several measures to improve it: the suction process was added before products' final folding and operators do it according to standard operation procedure requirements. Linting test method and acceptable criteria was stipulated to see the stipulated to see the suction results (
=
0. 38g/10 pieces). In the folding process, supplier used 1 cloth bag protect 100 pieces semi-finished products to avoid linting stuck onto the products during products' transfer. From the investigation, no abnormal situation happened in production and all linting test data for the past 12 months was within the acceptable range. Therefore, the root cause could not be determined. There is no action taken at this time, but supplier and cardinal will continue to monitor the trend of this type of incident.

Event Description

Pt reported that the blue towels or-1727bxg from the craniotomy pack sne59cnkso were linting and some of the lint got into the surgical field during a craniotomy. The towels were used to drape the mayo stand. Lint was found on the brain which was removed with irrigation and manual removal. No injury or adverse effect was reported. Patient demographics were not provided when requested. Report being filed for potential for injury.

• Brand Name: SDMC CRANIOTOMY PACK (CNKSN)254
• 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 11174760
• MDR Text Key: 226994049
• Report Number: 1423537-2021-00587
• Device Sequence Number: 1
• Product Code: OJG
• 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,user f

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SNE59CNKSO
• Device Catalogue Number: SNE59CNKSO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/14/2021 Patient Sequence Number: 1