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

Model Number SCV13PCCAA

Device Problems Material Fragmentation (1261); Material Frayed (1262); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2019

Event Type  malfunction  

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 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
• 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 dr; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 9572354
• MDR Text Key: 198600198
• Report Number: 1423537-2020-00391
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10888439470765
• UDI-Public: 10888439470765
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCV13PCCAA
• Device Catalogue Number: SCV13PCCAA
• Device Lot Number: 241830
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other