MAUDE Adverse Event Report: BD SAFETYGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Lot Number 8324525

Device Problem Fluid/Blood Leak (1250)

Patient Problem Underdose (2542)

Event Date 09/06/2019

Event Type  malfunction  

Event Description

The medication leaked from the needle during the injection and patient did not get a full dose.

• Brand Name: SAFETYGLIDE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD; 5859 farinon dr ste 200; san antonio TX 78249
• MDR Report Key: 9146032
• MDR Text Key: 160907298
• Report Number: 9146032
• 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: 09/09/2019

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: No Information
• Device Lot Number: 8324525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10585 DA