MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE ANGIOGRAPHY PACK (AN60D)758; GENERAL SURGERY TRAY (KIT)

Model Number SAN13AN60D

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

From the device history record, lot number 20200406-23-sh was finished on 05/08/2020.No exception was recorded in the device history record that could lead to the reported incident.From the investigation, there is no abnormal situation which occurred in production and device history record.A photo was provided, it showed there was floating fluff found on the surface of the solution in the container.The average linting data is 0.175 g / 10 pieces.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, we will continue to monitor the trend of this type of incident.According to our supplier, or towel is made of cotton, so cotton fiber is born.Supplier is 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/10pieces).In the folding process, supplier used one cloth pad under 10 0pieces semi-finished products to avoid linting stuck onto the products during product's transfer.

Event Description

Based on information from the customer the blue towel is laid on the drape to absorb fluids, reportedly if you touch it, small pieces come off on your hands or equipment.

• Brand Name: ANGIOGRAPHY PACK (AN60D)758
• Type of Device: 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
• Manufacturer (Section G): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 10642341
• MDR Text Key: 211430470
• Report Number: 1423537-2020-00538
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439684230
• UDI-Public: 10888439684230
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2020

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
• Device Operator: Health Professional
• Device Model Number: SAN13AN60D
• Device Catalogue Number: SAN13AN60D
• Device Lot Number: 455541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other