MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY CON EPID 20G NYL W/TUOHY

Catalog Number	PAIN9023
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, "the catheter is not threading.This is during epidural placement on the labor and delivery unit.Multiple physician providers reported same issue for multiple female patient for multiple dates over a few week period.This would occur in the middle of a procedure.They opened additional kits, at some points multiple additional kits were needed for same issue of the catheter not threading through needle.Additional needle sticks were required.The procedures would be completed".A sample is available 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
According to the facility, "the catheter is not threading.This is during epidural placement on the labor and delivery unit.".

• Common Device Name: TRAY CON EPID 20G NYL W/TUOHY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20351494
• Report Number: 1417592-2024-00876
• Device Sequence Number: 8024677
• Product Code: LRO
• UDI-Device Identifier: 40889942448716
• UDI-Public: 40889942448716
• 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): 10/02/2024

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: PAIN9023
• Device Lot Number: 24CLA005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/02/2024
• 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