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

Model Number SNE21BSDCH

Device Problem Material Frayed (1262)

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

Event Date 03/23/2021

Event Type  malfunction  

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 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
• 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: 11729536
• MDR Text Key: 247709553
• Report Number: 1423537-2021-00626
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10888439398649
• UDI-Public: 10888439398649
• 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: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: SNE21BSDCH
• Device Catalogue Number: SNE21BSDCH
• Device Lot Number: 484493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1