MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-VANTEX 7FR 3L 20CM CVC BUNDLE, CHOIC

Catalog Number	ECVC8040A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2023 after inserting the needle he was "unable to create negative pressure while attempting to aspirate blood".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 after inserting the needle he was "unable to create negative pressure while attempting to aspirate blood".The customer reported that the needle "had a hole or leak" and the needle was removed from the patient.The customer reported another device was "installed" and the procedure was able to be completed.The customer reported there were "no adverse outcomes".Sample requested for return evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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: DBD-VANTEX 7FR 3L 20CM CVC BUNDLE, CHOIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18088755
• Report Number: 3004519921-2023-00017
• Device Sequence Number: 5831083
• Product Code: OES
• UDI-Device Identifier: 10653160361589
• UDI-Public: 10653160361589
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2023

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: ECVC8040A
• Device Lot Number: 2022121690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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