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

Model Number DYNDV1815A

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2021

Event Type  malfunction  

Event Description

Upon starting a new iv, the iv start kit was opened.Immediately upon opening the kit, a coarse black hair was noted inside the package.Device and packaging saved for manufacturer investigation.Manufacturer response for iv start kit, ihn best practice (per site reporter).Equipment failure reported to both medline, manufacturer and concordance distributor.Waiting for reply with instructions and possible replacement or account credit.

Event Description

Upon starting a new iv, the iv start kit was opened.Immediately upon opening the kit, a coarse black hair was noted inside the package.Device and packaging saved for manufacturer investigation.Manufacturer response for iv start kit, ihn best practice (per site reporter) equipment failure reported to both medline, manufacturer and concordance distributor.Equipment was returned to medline.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 12452349
• MDR Text Key: 270873906
• Report Number: 12452349
• 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
• Type of Report: Initial,Followup
• Report Date: 09/09/2021,09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNDV1815A
• Device Catalogue Number: DYNDV1815A
• Device Lot Number: 201BB981
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1