MAUDE Adverse Event Report: MEDLINE INDUSTRIES - MUNDELEIN KIT IV STARTER WITH PRESSURE INF; I.V. START KIT

Catalog Number IVS3945

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2020

Event Type  malfunction  

Event Description

When clamp closed in iv the tubing was cut.Fda safety report id # (b)(4).

• Brand Name: KIT IV STARTER WITH PRESSURE INF
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES - MUNDELEIN; IL
• MDR Report Key: 10860576
• MDR Text Key: 217175417
• Report Number: MW5097955
• Device Sequence Number: 1
• Product Code: LRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IVS3945
• Device Lot Number: 2020082590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1