MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT 1000CC CRD CANISTER W/INTERNAL; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65652-511
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot number was provided by the customer: therefore, a review of the manufacturing device history record could not be performed.No sample was provided by the customer; therefore, an evaluation of the complaint device for deficiency of construction could not be performed.Discussions were held with engineering, quality and production personnel concerning the assignable cause and corrective actions for the liner crumpling when vacuum applied.Based on the information provided, a possible cause was a damaged, cracked outer canister or the lid not being seated properly.When the outer canister has a vacuum leak due to the lid not being seated properly or there is a crack to the outer canister, it will cause the liner to crumple as described in the complaint.Per the information received, when a new outer canister was used, the liner functioned as designed.Based on the investigation, no specific assignable cause could be determined, therefore, no specific corrective action could be completed.Key production, engineering and quality personnel have been made aware of this reported incident through the investigation process.Trending of past complaints indicate that this is the first reported incident for liner crumpled with suction in the past three calendar years.No corrective action will be taken at this time.The complaint information was informed to the relevant personnel for their awareness.We will continue monitoring customer complaints for trends, which may require further investigation.
Event or Problem Description
Based on information received from the customer reportedly the suction cannister was not working effectively despite being plugged in correctly.Noted inner cannister was allegedly crumpling with suction despite multiple staff ensuring it was working correctly.Reportedly a new inner cannister put in with same results.Reported a new outer cannister was used and found to be effective.It was reported when suction applied alone without being attached to anything that inner canister would reportedly crumple.There was no injury to the patient.

• Brand Name: 1000CC CRD CANISTER W/INTERNAL
• 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: 11055195
• Report Number: 1423537-2020-00580
• Device Sequence Number: 11438550
• Product Code: GCX
• UDI-Device Identifier: 10630140153396
• UDI-Public: 10630140153396
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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: 65652-511
• Device Catalogue Number: 65652-511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other