MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; IV EXT SET,60",2.0ML, M/F LUERLOCK,CLAMP

Catalog Number	DYNDTN1603
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022 during a procedure the iv tubing line cracked at the connection port resulting in the patient not receiving the required medication to effectively keep them asleep.According to the facility the patient required anesthesia intervention.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2022 during a procedure the iv tubing line cracked at the connection port resulting in the patient not receiving the required medication to effectively keep them asleep.Per the facility new tubing was required and the medication line was changed.According to the facility the patient required anesthesia intervention, however, the patient's recovery was not impacted.Photos have been returned that show the customer reported issue to be confirmed however a definitive root cause has not been established.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.

• Common Device Name: IV EXT SET,60",2.0ML, M/F LUERLOCK,CLAMP
• 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: 15188330
• Report Number: 1417592-2022-00134
• Device Sequence Number: 5602747
• Product Code: FPA
• UDI-Device Identifier: 10080196415076
• UDI-Public: 10080196415076
• Combination Product (Y/N): N
• Initial Reporter Country: BD
• 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): 08/08/2022

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 Catalogue Number: DYNDTN1603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/08/2022
• 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: Female