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

Catalog Number DYNDV1815A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Event Description

Rn opened iv start kit and noticed a foreign material which looked like a hair wrapped around tourniquet.No patient contact with product.Manufacturer response for iv start kit, (brand not provided) (per site reporter): equipment failure reported to (b)(4) customer service.Product sent out via (b)(6).

• Brand Name: IV START KIT
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1204 townline rd; 1 medline place; muldelein IL 60060
• MDR Report Key: 6858390
• MDR Text Key: 85797211
• Report Number: 6858390
• Device Sequence Number: 1
• Product Code: LRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYNDV1815A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1