MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY FRAZIER CONNECTING TUBING 61CM 50/CASE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Catalog Number	0031000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the 0031000, frazier connecting tubing 61cm 50/case, was being used during an unknown procedure on approximately (b)(6) 2024 date when it was reported ¿the clip fell off the tube and into the patient.¿.Further assessment questioning found that the clip was retrieved from the patient and no adverse event occurred.The procedure was completed, and it was also reported ¿no delay or patient impact.¿.There was no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of (b)(4) complaint, regarding (b)(4) device, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the (b)(6), frazier connecting tubing 61cm 50/case, was being used during an unknown procedure on approximately (b)(6) 2024 date when it was reported ¿the clip fell off the tube and into the patient.¿.Further assessment questioning found that the clip was retrieved from the patient and no adverse event occurred.The procedure was completed, and it was also reported ¿no delay or patient impact.¿.There was no report of injury, medical intervention, or prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: FRAZIER CONNECTING TUBING 61CM 50/CASE
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18924143
• Report Number: 3007305485-2024-00039
• Device Sequence Number: 17689243
• Product Code: GCX
• UDI-Device Identifier: 10653405000044
• UDI-Public: (01)10653405000044(17)280902(10)202309044
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: Health Professional
• Device Catalogue Number: 0031000
• Device Lot Number: 202309044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic