MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; CIRCUIT, 90"EXP,0BV,3L

Model Number	DYNJAA9015
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported loss of pressure in ventilation of patient after intubation and anesthesia circuit hook-up.Email received by facility representative, medline industries, inc., with additional information in regards to this incident.Reporter states, this incident occurred during a tonsillectomy procedure.Reporter states, "troubleshooting led to discovery of faulty/failure of anesthesia circuit likely due to a leak in the circuit.A new circuit was placed and then pressure was normalized." reporter states patient did require additional anesthesia/sedation because of this incident.No report of serious injury or follow-up care.Reporter states, the sample is no longer available for return and evaluation it was discarded.Reporter states, "patient is doing well." no further information has been provided.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported loss of pressure in ventilation of patient after intubation and anesthesia circuit hook-up.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CIRCUIT, 90"EXP,0BV,3L
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11388774
• Report Number: 1417592-2021-00027
• Device Sequence Number: 11706464
• Product Code: CAI
• UDI-Device Identifier: 10080196979226
• UDI-Public: 10080196979226
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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: DYNJAA9015
• Device Catalogue Number: DYNJAA9015
• Device Lot Number: 20IBC226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Weight: 95