MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CV PACK (CWSLC)829; GENERAL SURGERY TRAY (KIT)

Model Number	SCV44CWSLD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record revealed, lot# 20190503-25-sh, was manufactured on 09th may 2019.No exception was recorded in the device history record that could lead to the reported incident.Based on the supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.No sample was available at the time of the investigation.From the investigation, there is no abnormal situation that occurred in production.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no other action taken at this time, however, our supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer reported that lint from lap sponges, ls1818psa, from the cv pack, scv44cwsld, was falling into the vessels during cv cases.Lint was found in or around cavities, and barrier between instruments and the patient.There was a delay, but no injury to the patient.Mdr being reported based on potential risk to the patient.

• Brand Name: CV PACK (CWSLC)829
• 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: 9492507
• Report Number: 1423537-2019-00382
• Device Sequence Number: 1877433
• Product Code: LRO
• UDI-Device Identifier: 50888439542552
• UDI-Public: 50888439542552
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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: SCV44CWSLD
• Device Catalogue Number: SCV44CWSLD
• Device Lot Number: 285027
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other