MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; PEDI ANESTH CIRCUIT,60"UNI,1BV,1L,GSL

Model Number	DYNJAPF6002
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility during a procedure the bag to the circulation hose tore while the patient was under anesthesia.Per the facility the anesthesiologist noticed a drop in tidal volume and end tidal co2 capnography.Per the facility the anesthesiologist switched to manual ventilation and had difficulty ventilating the patient, even though the patient was 'spontaneously breathing without distress or increase in respiratory effort.Per the facility after 'switching to ambu bag, and changing the circuit everything went back to normal'.The sample was noted to be available, however, it was not returned for evaluation.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
According to the facility during a procedure the bag to the circulation hose tore while the patient was under anesthesia.

• Brand Name: Medline Industries, Inc.
• Common Device Name: PEDI ANESTH CIRCUIT,60"UNI,1BV,1L,GSL
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14120550
• Report Number: 1417592-2022-00053
• Device Sequence Number: 2356429
• Product Code: CAH
• UDI-Device Identifier: 10080196893379
• UDI-Public: 10080196893379
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJAPF6002
• Device Catalogue Number: DYNJAPF6002
• Device Lot Number: 22NBA728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown