MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CATH LAB ACCESSORY TRAY (CLSMJ)673; GENERAL SURGERY TRAY (KIT)

Model Number	SAN5BCLSMK
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.The device is being returned for investigation, but not yet received.A follow-up report will be filed once the results have been completed.
Event or Problem Description
The customer reported linting blue non-xray cotton towels, 101625, from the cath lab accessory tray/ san5bclsmk.The procedure performed was an coronary angiogram.The cotton towels were used over sterile drapes to hold down equipment on the sterile field.The staff changed out the flush basin causing minimal delay.There was no patient injury.
Additional Manufacturer Narrative
Based on the supplier investigation, the device history record review for lot number 11sf04-sh did not indicate any exception that could lead to the reported incident.The average linting data is 0.2g / 10 pieces.Two pieces of the sample was returned for investigation.The samples were used and lint was wrapped into a piece of gauze sponge.Testing result for linting is 0.002g, which is within the specification =0.38g/10 pieces.According to the supplier, the towel is made of cotton, so lint is born and inevitable.The manufacturer 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, the manufacturer 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 occurred 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 other action taken at this time, however, our supplier will continue to monitor the trend of this type of incident.

• Brand Name: CATH LAB ACCESSORY TRAY (CLSMJ)673
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 9468192
• Report Number: 1423537-2019-00380
• Device Sequence Number: 13944311
• Product Code: LRO
• UDI-Device Identifier: 10888439230321
• UDI-Public: 10888439230321
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: SAN5BCLSMK
• Device Catalogue Number: SAN5BCLSMK
• Device Lot Number: 299671
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 92