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

Model Number DYNJAA9015

Device Problem No Pressure (2994)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  malfunction  

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 Description

It was reported loss of pressure in ventilation of patient after intubation and anesthesia circuit hook-up.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: CIRCUIT, 90"EXP,0BV,3L
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11388774
• MDR Text Key: 264306920
• Report Number: 1417592-2021-00027
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10080196979226
• UDI-Public: 10080196979226
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJAA9015
• Device Catalogue Number: DYNJAA9015
• Device Lot Number: 20IBC226
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 95