MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY POOLE INSTRUMENT W/3.05 MTR TUBING 20/CS; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number	0035070
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, 0035070, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This will be reported as a malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received three 0035070 in unopened original packaging.Lot number was verified.Performed a visual inspection, one seal is opened at the end of the packaging, one device is encroaching the seal, and one package does not have any signs of abnormalities or defects.Performed a functional inspection, the devices were dye leak tested per tm-10-217 rev.F which indicated that the packaging had a breach to sterility on one out of the three packages.A root cause cannot be determined; however, based on the photographic evidence, a possible cause of this event could be the device breached the seal.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.(b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: POOLE INSTRUMENT W/3.05 MTR TUBING 20/CS
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• 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: john berga ; 11311 concept blvd; largo, FL 33733 ; 7273995358
• MDR Report Key: 18362915
• Report Number: 3007305485-2023-00253
• Device Sequence Number: 12765955
• Product Code: GCX
• UDI-Device Identifier: 10653405000419
• UDI-Public: (01)10653405000419(17)270516(10)202205174
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 12/20/2023

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: 0035070
• Device Lot Number: 202205174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic