MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CPT, BASIC IR PACK (IRSHF)159; RADIOGRAPHIC CONTRAST TRAY

Model Number	SANHFIRSHF
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Customer reported that the towels pwtb04-stm from the basic ir pack sanhfirshf are getting lint balls on them during an angiogram procedure.The particulates are also from the foam tray.This is problematic because they can become an embolic for the patient.There was no injury or delay reported.Report being filed for potential for injury.
Additional Manufacturer Narrative
Supplemental report is being filed due to the sample towels pwtb04-stm were received from the customer for investigation following the submission of the initial mdr report submitted on 2/3/2021.It was determined the towels were not the source of particulates found in the basic ir pack sanhfirshf.No further action is required at this time.

• Brand Name: CPT, BASIC IR PACK (IRSHF)159
• Common Device Name: RADIOGRAPHIC CONTRAST TRAY
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 11276307
• Report Number: 1423537-2021-00589
• Device Sequence Number: 3543673
• Product Code: OIO
• UDI-Device Identifier: 10888439588224
• UDI-Public: 10888439588224
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: Health Professional
• Device Model Number: SANHFIRSHF
• Device Catalogue Number: SANHFIRSHF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other