MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY GOLDLINE, BUTTON, HOLSTER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	130309A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During incoming inspection, the distributor rejected this device, 130309a, goldline, button, holster, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received eight 130309a in unopened original packaging.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach in the seal; however, the device was encroaching into the seal.Performed a functional inspection, the device was dye leak tested which indicated that the packaging had an insufficient heat seal on five out of the eight devices.Root cause cannot be determined; however, based upon evaluation of the device a possible cause of this event could be that the device was encroaching the seal.(b)(4).Per the instructions for use, the user is advised the following: inspect and test each device before use.Sterility guaranteed unless package has been opened, broken or damaged.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: GOLDLINE, BUTTON, HOLSTER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 19730664
• Report Number: 3007305485-2024-00099
• Device Sequence Number: 18224656
• Product Code: GEI
• UDI-Device Identifier: 30653405056151
• UDI-Public: (01)30653405056151(17)270614(10)202206155
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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: Other
• Device Catalogue Number: 130309A
• Device Lot Number: 202206155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic