* DYNDBARD8

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-04 for * DYNDBARD8 manufactured by Medline Industries, Inc..

Event Text Entries

[20979314] During a procedure to start a peripheral intravenous (iv) line in the patient's left wrist, the clinician attempted to connect an extension set from the iv start kit and the connection immediately began to leak. Several attempts made to loosen, disconnect and re-thread luer connection had failed. Two more attempts to use extension sets from additional opened iv start kits still failed to correct the leak. The clinician then opened an individual extension set from a different manufacturer and a tight non-leak connection was made. The clinician decided to remove the iv catheter along with all leaking extension sets and send them to the biomedical engineering department for logging and manufacturer analysis. An addition iv catheter was started along with the second manufacturer set with no additional leaks or issues. There have been additional reported failures or leaks when using the components of the iv start kit. This is an assembled kit with items from various manufacturers. The biomedical engineering department notes that the assembler of kit is the manufacturer of the device (iv start kit). No individual component manufacturer information is provided in the packaging. Manufacturer response: we are attempting resolution on an ongoing issue.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4544365
• MDR Report Key: 4544365
• Date Received: 2015-02-04
• Date of Report: 2015-02-04
• Date of Event: 2015-01-17
• Report Date: 2015-02-04
• Date Reported to FDA: 2015-02-04
• Date Reported to Mfgr: 2015-02-25
• Date Added to Maude: 2015-02-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: IV START KIT
• Product Code: LRS
• Date Received: 2015-02-04
• Model Number: DYNDBARD8
• Catalog Number: DYNDBARD8
• Lot Number: 14IB2246
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDLINE INDUSTRIES, INC.
• Manufacturer Address: ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-02-04