MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE PACEMAKER PACK (PCCAL)665; GENERAL SURGERY TRAY (KIT)

Model Number	SCV13PCCAA
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.No sample returned at the time of the investigation, only photo of the defect sample was provided.The edge of this product was not completely folded well.From the investigation, the supplier determined the root cause as the gauze roll was not properly set up to folding machine, the position of gauze roll will be uneven, it will caused one side of the gauze product is not completely folded well.The operator failed to sort out the defective sample.The complaint information was sent to the relevant sectors for their awareness.There is no further action taken at this time, but the supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported the sponge edges appear crumbly and are frayed.Reportedly, fragments of the sponge were noted within the pack when opened on the table before the procedure.

• Brand Name: PACEMAKER PACK (PCCAL)665
• 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: 9572354
• Report Number: 1423537-2020-00391
• Device Sequence Number: 16629851
• Product Code: LRO
• UDI-Device Identifier: 10888439470765
• UDI-Public: 10888439470765
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 01/09/2020

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: SCV13PCCAA
• Device Catalogue Number: SCV13PCCAA
• Device Lot Number: 241830
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other