MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; PIV BUNDLE KIT

Catalog Number	IVS3565B
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, there have been multiple incidences where a "leakage" is occurring due to the "green piece" breaking on the iv.The customer reported when the incident occurs, they "attempt to save the line" but "up to 90%" of the devices that fail require a new iv to be inserted.The customer reported there has been no serious injury, medical intervention, or follow up care related to the reported incident.No additional information is available.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.
Event or Problem Description
According to the customer, there have been multiple incidences where a "leakage" is occurring due to the "green piece" breaking on the iv.
Additional Manufacturer Narrative
Update to h6- investigation conclusions.

• Common Device Name: PIV BUNDLE KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19105553
• Report Number: 3004519921-2024-00022
• Device Sequence Number: 20798019
• Product Code: LRS
• UDI-Device Identifier: 00653160364286
• UDI-Public: 00653160364286
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 05/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: IVS3565B
• Device Lot Number: 2023071090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/23/2024
• 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