MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ONGUARD SAFETY BLOOD COLLECTION NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number DYNDSBCN21G

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2021

Event Type  malfunction  

Event Description

Onguard collection needle by medline.These needles have come loose from the hub several times in the past month.The safety device will spin around and come off the hub.The tube frequently ejects from the hub and requires physical pressure to hold it into place.

• Brand Name: ONGUARD SAFETY BLOOD COLLECTION NEEDLE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 12099523
• MDR Text Key: 259447655
• Report Number: 12099523
• Device Sequence Number: 1
• Product Code: FMI
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNDSBCN21G
• Device Catalogue Number: DYNDSBCN21G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2021
• Event Location: Other
• Date Report to Manufacturer: 07/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1