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

Model Number 0035070

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

One 0035070 returned unopened in original packaging.The lot number of the device - 202008055 was verified.The device encroached into the seal on the packaging.The device was dye leak tested which indicated that the packaging had an insufficient heat seal, the dye leaked into the gap in the seal caused by the device encroaching.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.(b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.

Event 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.

• Brand Name: POOLE INSTRUMENT W/3.05 MTR TUBING 20/CS
• Type of Device: 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
• MDR Report Key: 12553511
• MDR Text Key: 282290424
• Report Number: 3007305485-2021-00386
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10653405000419
• UDI-Public: (01)10653405000419(17)250804(10)202008055
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0035070
• Device Catalogue Number: 0035070
• Device Lot Number: 202008055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1