MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT LINER SUCTION 1500CC; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65651-920C
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility for investigation.Once the investigation is completed a follow-up report will be filed.
Event or Problem Description
Customer reported inadequate scope suction due to a small hole in the canister liner during egd variceal banding procedure.The patient continued to bleed, and was transferred to icu.Reportedly, the bands were difficult to place due to lack of suction.When canister liner was removed bloody water and secretions had been pulled and there was blood in the liner and canister.Lot number -undefined.
Additional Manufacturer Narrative
No lot number was provided by the customer; therefore, a review of the manufacturing device history record was not possible.No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.Note: if the event sample is received at a later date and provides a different conclusion, an addendum report will be written.Trending of past product quality reports indicate that this is the 1st reported incident for a hole in the liner for the 65651-920c product code in the past three calendar years.Twenty visual quality inspections for holes in the product and 5 functional quality inspections for burst and underwater leak are completed hourly for each lot manufactured.During these tests any hole in the product would be detected and the product would be placed on hold.The non-conforming history for part number 65651-920c was reviewed.No non-conformances were detected during the past 12-months for holes in the product.Without a specific assignable cause, no specific corrective actions can be completed; however, we will continue to monitor concerns such as these for possible future actions.Key production and quality personnel have been made aware of this reported incident through the investigation process.

• Brand Name: LINER SUCTION 1500CC
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 9112928
• Report Number: 1423537-2019-00348
• Device Sequence Number: 14043454
• Product Code: GCX
• UDI-Device Identifier: 50885380029088
• UDI-Public: 50885380029088
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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 Model Number: 65651-920C
• Device Catalogue Number: 65651-920C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/23/2019
• Patient Sequence Number: 1