MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE SDMC CRANIOTOMY PACK (CNKSN)254; NEUROLOGICAL TRAY

Model Number	SNE59CNKSO
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record could not be verified as lot number was not provided.There is no occurrence reported in the past 12 months.No sample was available for investigation.According to the supplier, the or towel is made of cotton, so lint is born and inevitable.The intended use of the or towel is used for applying medication or absorbing small amounts of body fluids from a patient's body surface.Supplier has worked with cardinal to better control the linting and has implemented several measures to improve it: the suction process was added before products' final folding and operators do it according to standard operation procedure requirements.Linting test method and acceptable criteria was stipulated to see the stipulated to see the suction results (=0.38g/10 pieces).In the folding process, supplier used 1 cloth bag protect 100 pieces semi-finished products to avoid linting stuck onto the products during products' transfer.From the investigation, no abnormal situation happened in production and all linting test data for the past 12 months was within the acceptable range.Therefore, the root cause could not be determined.There is no action taken at this time, but supplier and cardinal will continue to monitor the trend of this type of incident.
Event or Problem Description
Pt reported that the blue towels or-1727bxg from the craniotomy pack sne59cnkso were linting and some of the lint got into the surgical field during a craniotomy.The towels were used to drape the mayo stand.Lint was found on the brain which was removed with irrigation and manual removal.No injury or adverse effect was reported.Patient demographics were not provided when requested.Report being filed for potential for injury.

• Brand Name: SDMC CRANIOTOMY PACK (CNKSN)254
• 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: 11174760
• Report Number: 1423537-2021-00587
• Device Sequence Number: 2385222
• Product Code: OJG
• UDI-Device Identifier: 10888439602913
• UDI-Public: 10888439602913
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2021

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: SNE59CNKSO
• Device Catalogue Number: SNE59CNKSO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other