MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE SHALTONI IR PACK (SRUTA)629; RADIOGRAPHIC CONTRAST TRAY

Model Number	SAN44SRUTB
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
Based on the supplier investigation, the device history record could not be reviewed as a lot number was not provided.Supplier reviewed the records over the last 2 years and no abnormal situation was found.No sample was returned for investigation, only a photo was provided showing blue lint.According to the supplier, the or towel is made of cotton, so cotton fiber is a normal characteristic.Supplier continuously is 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/10 pieces).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, there is no abnormal situation that 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.
Event or Problem Description
Customer reported that the blue ,cotton or towels pwtb04-stm, from the ir pack san44srutb are shedding fibers onto various wires and catheters during an intracranial embolization.The towels were used for fluid absorption outside the drape.There was no injury or delay.No patient demographics were provided upon request.Cardinal health is filing a report for malfunction.

• Brand Name: SHALTONI IR PACK (SRUTA)629
• Common Device Name: RADIOGRAPHIC CONTRAST 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: 10103420
• Report Number: 1423537-2020-00464
• Device Sequence Number: 3361443
• Product Code: OIO
• UDI-Device Identifier: 10888439526622
• UDI-Public: 10888439526622
• 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
• Report Date (Section B): 05/29/2020

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: SAN44SRUTB
• Device Catalogue Number: SAN44SRUTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/29/2020
• 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