MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE NEURO PACK (BSHNE)601; NEUROLOGICAL TRAY

Model Number SNE37BSHNF

Device Problem Material Separation (1562)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

Based on supplier investigation, lot number 20210722-23-sh was reviewed.The device history record review did not indicate any exception that could lead to the reported incident.The average linting data is (b)(4).There was no sample available for investigation, but a photo was provided that showed some blue objects on the white gauze.According to supplier, operating room 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 as follows: suction machines have been installed in the grey cloth rolling process, dyeing process, and cutting process, the suction process was added before product's final folding, and workers process according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(b)(4) in the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid lint from being stuck onto the product during product's transfer.Based on the investigation, there were no abnormalities found during production of the or towels; therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, supplier will continue to monitor the trend of this type of incident.

Event Description

Customer has reported that they are experiencing linting from the operating room towels.Customer has indicated that the towels are leaving lint all over the gloves of the surgeon and on the technologists.The blue lint is also sticking to the patient when cleaning their skin at the conclusion of the case.There have been no injuries reported.

• Brand Name: NEURO PACK (BSHNE)601
• 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 ; 8478874151
• MDR Report Key: 13860772
• MDR Text Key: 287679547
• Report Number: 1423537-2022-00741
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10888439124071
• UDI-Public: 10888439124071
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: SNE37BSHNF
• Device Catalogue Number: SNE37BSHNF
• Device Lot Number: 722955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/23/2022
• Date Device Manufactured: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1