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

Model Number	65651-920C
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing device history record for lot number j207-421 provided by the customer was performed.The product was manufactured 07-25-22.This investigation determined that all products were manufactured, inspected, and released in accordance with our established specifications for quality and efficacy.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 concerning the assignable cause and corrective actions for excessive glue residue at the flex pack-out operations.A scale is utilized to ensure the proper amount of glue is used to attach the lids to the liners.Lot inspection procedures are performed including sampling product for proper glue weight and leak testing.It is possible the product involved in this reported incident was not included in the sampling plan. based on the investigation, no specific assignable cause could be determined; therefore, no specific corrective action could be completed.The product in this reported incident was manufactured prior to the updated equipment for the glue extruder and the accompanying validation.Key production and quality personnel have been made aware of this reported incident through this investigation process.No further action is planned at this time.
Event or Problem Description
Patient was in or for trial of forceps.After birth of baby required suctioning at panda warmer.Suction did not work.Neonatal resuscitation equipment checked by nurses when setting up for assisted birth and was noted to be functioning.Wall suction used as needed.No adverse outcome to baby.Issue with suction on panda warmers functioning intermittently brought to birth unit leadership attention by a staff member.It was noted that suction would be checked and functioning by nurse and then when needed for use it would not function.

• 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
• Manufacturer (Section G): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874152
• MDR Report Key: 16091791
• Report Number: 1423537-2023-00871
• Device Sequence Number: 11273732
• Product Code: GCX
• UDI-Device Identifier: 50885380029088
• UDI-Public: 50885380029088
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2023

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: J207-421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown