MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CL ANGIOGRAPHY PACK (ADTDB)202; GENERAL SURGERY TRAY (KIT)

Model Number	SAN41ADTD4
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number 20190916-23-sh was manufactured on 09/19/2019.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is 0.167g / 10 pieces.No sample has been returned for investigation at this time.However, photos were provided.It was noted there was lint found on instruments.From the investigation, there is no abnormal situation that happened in production.The linting test data were within the acceptable range, therefore, the root cause could not be determined from this investigation.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, however, supplier will continue to monitor the trend of this type of incident.According to supplier, or towel is made of cotton, so cotton fiber is born.Supplier continuously 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.
Event or Problem Description
Per customer, they reportedly found blue foreign material on instruments / supplies.They reported no injury to patient.

• Brand Name: CL ANGIOGRAPHY PACK (ADTDB)202
• 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: 9910051
• Report Number: 1423537-2020-00445
• Device Sequence Number: 16926951
• Product Code: LRO
• UDI-Device Identifier: 10888439667899
• UDI-Public: 10888439667899
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2020

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: SAN41ADTD4
• Device Catalogue Number: SAN41ADTD4
• Device Lot Number: 365484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other