MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE RMC NEURO (BSDCG)195; NEUROLOGICAL TRAY

Model Number	SNE21BSDCH
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, a review of the device history record for lot number 191130958sh, revealed no exception was recorded that could lead to the reported incident.According to the supplier, workers perform the process operation in strict compliance with the standard operation procedure of gauze swab production.The actual complaint sample is not available at the time of investigation; therefore, the supplier was unable to determine the root cause.The supplier will continue to monitor trends for this type of incident.
Event or Problem Description
Customer reported the sponge gauze(c-nxr4416a) from neurological tray(sne21bsdch) was unraveling during lumbar disc procedure.The gauze sponge was used for removal and blotting of blood and fluids during the procedure.Reportedly, fraying from the gauze sponge was found on the patient and on scrub tech¿s hands.There was no injury, adverse effect or complications.No patient demographics were provided.

• Brand Name: RMC NEURO (BSDCG)195
• Common Device Name: NEUROLOGICAL TRAY
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 11729536
• Report Number: 1423537-2021-00626
• Device Sequence Number: 14426898
• Product Code: OJG
• UDI-Device Identifier: 10888439398649
• UDI-Public: 10888439398649
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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: SNE21BSDCH
• Device Catalogue Number: SNE21BSDCH
• Device Lot Number: 484493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1