MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; I.V. START KIT

Model Number DYND74260

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

The tape that the iv start kit contains does not stick.The nurse has to go find additional tape which mitigates the reason for buying the kit.No patient was harmed due to this.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15326851
• MDR Text Key: 298978385
• Report Number: 15326851
• Device Sequence Number: 1
• Product Code: LRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYND74260
• Device Catalogue Number: DYND74260
• Device Lot Number: (10)22EBG9281130/2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1