MAUDE Adverse Event Report: MEDLINE INDUSTRUIES LP Medline; TEMPERATURE PROBE 9FR W/400 SERIES TEMP

Model Number	DYNJAER4009
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the facility that the temperature probe was inserted into the patient and ended up in the patient's right main stem.(pt.#2).No additional information is available.
Additional Manufacturer Narrative
It was reported by the facility that the temperature probe was inserted into the patient and ended up in the patient's right main stem.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample has not been returned for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

• Brand Name: Medline
• Common Device Name: TEMPERATURE PROBE 9FR W/400 SERIES TEMP
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 12820365
• Report Number: 1417592-2021-00203
• Device Sequence Number: 14612102
• Product Code: BZT
• UDI-Device Identifier: 10080196551705
• UDI-Public: 10080196551705
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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: DYNJAER4009
• Device Catalogue Number: DYNJAER4009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/16/2021
• 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: Other
• Patient Sex: Unknown