MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE LUMBAR PACK (LUUNB)625; GENERAL SURGERY TRAY (KIT)

Model Number	SOP41LUUNC
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, the device history record could not be reviewed, as the lot number was not provided.At this time the samples have not been received at the plant, therefore the samples have not been evaluated as of this time.Operating room towels are made of cotton, so lint is born and inevitable.The supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: 1) suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.2) the suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.3) linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10 pieces).4) in the folding process, the supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.
Event or Problem Description
Based on information received from the customer, the blue or towels are reportedly linting.There was no patient injury.
Additional Manufacturer Narrative
Forty pieces of samples were returned for investigation.The suction test was conducted on the returned samples.No obvious abnormal situation was found on the samples.Or towels are made of cotton, so lint is born and inevitable.We are continuously working to better control the linting and have implemented the following: 1.Suctions machines have been installed in grey cloth rolling process, dyeing process and cutting process.2.The suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.3.Linting test method and acceptable criteria was stipulated to see the suction results.(=0.38g/10 pieces).4.In the folding process, the supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, however, will continue to monitor the trend of this type of incident.

• Brand Name: LUMBAR PACK (LUUNB)625
• 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: 9513310
• Report Number: 1423537-2019-00387
• Device Sequence Number: 2756738
• Product Code: LRO
• UDI-Device Identifier: 10888439302288
• UDI-Public: 10888439302288
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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: No Information
• Device Model Number: SOP41LUUNC
• Device Catalogue Number: SOP41LUUNC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other