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

Model Number DYNJAPF6002

Device Problems Gas/Air Leak (2946); Material Split, Cut or Torn (4008)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/21/2022

Event Type  Injury  

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 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.
• Type of Device: 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
• MDR Text Key: 290545993
• Report Number: 1417592-2022-00053
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 10080196893379
• UDI-Public: 10080196893379
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: DYNJAPF6002
• Device Catalogue Number: DYNJAPF6002
• Device Lot Number: 22NBA728
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/15/2022
• 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