MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE IR NEURO PACK 629; NEUROLOGICAL TRAY

Model Number	SAN44IRUTA
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that the blue, sterile, cotton or towels pwtb04-stm, from the ir neuro pack san44iruta/lot 375598 are shedding fibers onto various wires and catheters during a intracranial embolization.The towels were used for fluid absorption outside the drape.There was no injury or delay.No patient demographics were provided after attempts.Cardinal health is proactively filing a report for malfunction.
Additional Manufacturer Narrative
Supplemental report is being filed since the results of investigation are available.From the device history record, lot#20191112-23-sh was manufactured on 15th nov 2019.No exception was recorded in the device history record that could lead to the reported incident.Supplier reviewed records over the last 2 years, and no abnormal situation was found.A sample was not returned at the time of the investigation but a photo of lint was provided for review.According to supplier, or towel is made of cotton, so cotton fiber is a natural characteristic.Supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: a.Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.B.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.C.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10 pieces).D.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 informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.

• Brand Name: IR NEURO PACK 629
• 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: 10102513
• Report Number: 1423537-2020-00462
• Device Sequence Number: 3361442
• Product Code: OJG
• UDI-Device Identifier: 10888439390407
• UDI-Public: 10888439390407
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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: SAN44IRUTA
• Device Catalogue Number: SAN44IRUTA
• Device Lot Number: 375598
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/05/2020
• 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