MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE ANGIO PACK (ANEJD)644; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN43ANEJE
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the reported incident is ongoing.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Blue cotton towels have excessive lint.No injury reported.
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) review did not indicate any exception that could lead to the reported incident.The average linting data is 0.106g / 10 pieces.No sample was available at the time of the investigation, but photos were provided.Photos shows the surface of the towel turns white and no lint can be found.Supplier was unable to determine the defect source based on the photos alone.According to supplier, or towel is made of cotton, so cotton fiber is born.The supplier 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/10pieces).D.In the folding process, supplier used one cloth pad under 100pieces semi-finished products to avoid linting stuck onto the products during product's transfer.The investigation results revealed no abnormal situation happened during production.The root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.No action taken at this time, but supplier will continue to monitor trends for this type of incident.

• Brand Name: ANGIO PACK (ANEJD)644
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY 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: 11068789
• Report Number: 1423537-2020-00582
• Device Sequence Number: 14099613
• Product Code: OEQ
• UDI-Device Identifier: 10888439908619
• UDI-Public: 10888439908619
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/11/2021

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: SAN43ANEJE
• Device Catalogue Number: SAN43ANEJE
• Device Lot Number: 510054
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/11/2021
• Patient Sequence Number: 1