MAUDE Adverse Event Report: BD BD U-100 INSULIN SYRINGE; SYRINGE, PISTON

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/18/2016

Event Type  malfunction  

Event Description

Insulin drawn into syringe, replaced cap to transport to room.When we removed cap to administer medication, safety slide came off with cap requiring rn to recap needle after being exposed to patient bodily fluid.

• Brand Name: BD U-100 INSULIN SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD; 5859 farinon dr ste. 200; san antonio TX 78249
• MDR Report Key: 5837279
• MDR Text Key: 50881655
• Report Number: 5837279
• Device Sequence Number: 1
• Product Code: FMF
• 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: 07/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR