MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; TRAY,18G CPNB, 20G STYLETED

Model Number	DYNJRA9040
Health Effect - Clinical Codes	Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2022 an epidural was placed and the patient experienced dizziness, hypotension, and difficulty breathing requiring rescue breaths and medical intervention.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 an epidural was placed and the patient experienced dizziness, hypotension, and difficulty breathing requiring rescue breaths and medical intervention.Per the facility the epidural was placed at 'l3-l4 and after administering lidocaine with epi, marcaine, and fentanyl the patient went limp'.Per the facility, the staff provided oxygen via ambubag as well as ephedrine.Respirations were given 'for about 5 min until the patient had more vigorous respiratory effort'.Per the facility the vital signs stabilized and the epidural catheter was removed with the tip noted to be intact.According to the facility the patient recovered from the event.The exact device is not available to be returned for evaluation, but an additional sample has been returned and is pending evaluation.No additional information is available at this time.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.

• Brand Name: Medline Industries, Inc.
• Common Device Name: TRAY,18G CPNB, 20G STYLETED
• 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: 15113418
• Report Number: 1417592-2022-00117
• Device Sequence Number: 5553929
• Product Code: OFT
• UDI-Device Identifier: 10193489830514
• UDI-Public: 10193489830514
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: DYNJRA9040
• Device Catalogue Number: DYNJRA9040
• Device Lot Number: 22BBB921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 22 YR
• Patient Sex: Female
• Patient Weight: 99 KG