MAUDE Adverse Event Report: BD MEDICAL SURGICAL SYSTEMS BD BLUNT FILL NEEDLE

Model Number 305180

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2015

Event Type  malfunction  

Event Description

In a bd blunt fill needle sealed packet, there was an add'l metal like object seen inside the packet alongside the needle.The needle was not opened and, therefore was not used.

• Brand Name: BD BLUNT FILL NEEDLE
• Type of Device: BLUNT FILL NEEDLE
• Manufacturer (Section D): BD MEDICAL SURGICAL SYSTEMS; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 4924328
• MDR Text Key: 6052711
• Report Number: MW5044381
• Device Sequence Number: 1
• Product Code: FMI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/07/2015

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 Expiration Date: 03/01/2020
• Device Model Number: 305180
• Device Catalogue Number: 305180
• Device Lot Number: 5059930
• Other Device ID Number: (01) 00382903051800009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1