MAUDE Adverse Event Report: TX134 TX-EL PASO-DON HASKINS KIT, NEURO (JEGI )679; NEUROLOGICAL TRAY

Model Number	PN21NJEGJ
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample was returned for investigation.The supplier stated they could not review the device history record during their investigation because the lot number was not provided.However, supplier reviewed their records for the last 2 years and did not find anything abnormal.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.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38 g/10 pieces).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, 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.There is no action taken at this time, but the supplier will continue to monitor trends for this type of incident.
Event or Problem Description
Customer reported linting was discovered while the surgeon was drying his hands after scrubbing for a neurosurgery.No injury or delay noted.The sample was discarded.

• Brand Name: KIT, NEURO (JEGI )679
• Common Device Name: NEUROLOGICAL TRAY
• Manufacturer (Section D): TX134 TX-EL PASO-DON HASKINS; 1320 don haskins; el paso TX 79936
• MDR Report Key: 10399263
• Report Number: 1423537-2020-00497
• Device Sequence Number: 2605935
• Product Code: OJG
• UDI-Device Identifier: 10888439428698
• UDI-Public: 10888439428698
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: PN21NJEGJ
• Device Catalogue Number: PN21NJEGJ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/12/2020
• Patient Sequence Number: 1