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

Catalog Number DXNDV-1857

Device Problems Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/01/2020

Event Type  malfunction  

Event Description

A long black hair was found in an iv start kit that was going to be used today.It was entwined in the chg cleansing pad and then to the glue of the packaging.Manufacturer response for iv start kit, (brand not provided) (per site reporter).Defective product and form received in supply chain and sent to vendor for investigation.

• Brand Name: IV START KIT
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 10683079
• MDR Text Key: 211454746
• Report Number: 10683079
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DXNDV-1857
• Device Lot Number: 20BBR882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1