MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRIPLE LUMEN CVC INSERTION BUNDLE

Catalog Number	ECVC5020A
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by the customer contact that on (b)(6) 2023 "upon attempting to retract the guide wire back out of the needle (needle still in the vessel) the guidewire got stagged caught on the needle.The wire would not retract out of the needle, but became a spring like device and starting to uncoil with the pulled pressure.At this point the while and the needled had to be removed".It was reported that due to this, "needle and guidewire removed another kit was retrieved and tlc placed".A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
Event or Problem Description
The wire would not retract out of the needle.

• Common Device Name: TRIPLE LUMEN CVC INSERTION BUNDLE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18232822
• Report Number: 3004519921-2023-00020
• Device Sequence Number: 3225470
• Product Code: LRO
• UDI-Device Identifier: 10653160364979
• UDI-Public: 10653160364979
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/29/2023

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
• Device Catalogue Number: ECVC5020A
• Device Lot Number: 2023091390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/29/2023
• 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