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

Catalog Number DYNDTN1603

Device Problem Crack (1135)

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

Event Date 07/27/2022

Event Type  Injury  

Event 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.

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.

• Type of Device: 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
• MDR Text Key: 297496363
• Report Number: 1417592-2022-00134
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BD
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNDTN1603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2022
• 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
• Patient Sex: Female