MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE KIT,NEURO SPINE (SLCN )470; NEUROLOGICAL TRAY

Model Number PNVXNSLC9

Device Problem Material Separation (1562)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

From the device history record, lot# 20210106-23-sh was finished on 21st jan 2021.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is 0.133g/10pcs.No sample returned for investigation.According to the supplier, the operating room towel is made of cotton, so cotton fiber is born.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.(=0.38g/10pieces).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 or dhr.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, but the supplier will continue to monitor the trend of this type of incident.

Event Description

Customer reported the blue cotton operating room towels pwtb04-stm from the neuro spine kit pnvxnslc9 are linting causing concerns for surgical site infections.There was no adverse effect to the patient.The scrub and doctors noticed the lint on the instruments, especially when they were working under the microscope.No other information was provided when requested.

Manufacturer Narrative

Supplemental report being filed since the sample was received after the initial report was filed.2pcs of samples for pwtb04-stm were returned for investigation.No lint was found during visual inspection.Suction test was conducted and the linting data is 0.04g/2pcs which meets specifications.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10pieces).From the investigation, there is no abnormal situation happened in production or dhr.Therefore, the root cause could not be determined.

• Brand Name: KIT,NEURO SPINE (SLCN )470
• 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
• MDR Report Key: 12112394
• MDR Text Key: 261915420
• Report Number: 1423537-2021-00647
• Device Sequence Number: 1
• Product Code: OJG
• UDI-Device Identifier: 10195594090180
• UDI-Public: 10195594090180
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

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: PNVXNSLC9
• Device Catalogue Number: PNVXNSLC9
• Device Lot Number: 621408
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other