MAUDE Adverse Event Report: BD BD INSULIN SYRINGE; SYRINGE, PISTON

Lot Number 717906

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/13/2018

Event Type  malfunction  

Event Description

Patient reported that 4 syringes of bd insulin syringe 0.5ml; 30g 0.5in malfunctioned.Stated that when orange needle cover/safety cover was removed, needle disconnected as well.According to patient report, lot number may have been 717906.Patient did not return product to pharmacy.Diagnosis or reason for use: diabetes.

• Brand Name: BD INSULIN SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 7467772
• MDR Text Key: 106868579
• Report Number: MW5076805
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 08290328466
• UDI-Public: 08290328466
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 717906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 98