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	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product sample is available, but has not been received at the manufacturing facility at that this time.A follow-up report will be filed once investigation has been completed based on sample evaluation.
Event or Problem Description
Staff reported difficulty securing the 90 degree adapter to the top of the flexible canister.Even with downward pressure and twisting motion, the adapter could twist off with ease.As a result, the adapter fell off during a pediatric code and the team lost suction.The patient was not injured.
Additional Manufacturer Narrative
No lot number was provided by the customer; therefore, a review of the manufacturing device history record to determine if any deviations took place during the manufacture of the product could not be performed.One flex liner/sub-assembly unit was received at our facility for evaluation.A visual examination of the returned unit was completed by quality and engineering management.No visual non-conformities were noted as the adapter was found secured to the patient port.Dimensional measurements for outside diameter of the patient port on the lid and inside diameter of the adapter was completed on the returned unit by our laboratory personnel.Both the patient port of the lid and adapter measured within the approved quality specification.Note: the returned unit was not the actual event sample; therefore, if the actual event sample is received at a later date and provides a different conclusion, an addendum report will be written.Without a lot number or the actual event sample involved in the customer incident and duplication of the non-conformance, no specific assignable cause can be determined regarding the reported incident as the returned unit measured within the approved quality specification.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: 8103071
• Report Number: 1423537-2018-00246
• Device Sequence Number: 2261289
• Product Code: GCX
• UDI-Device Identifier: 50885380029088
• UDI-Public: 50885380029088
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/17/2018
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 40