MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; INSULIN SYRINGE WITH NEEDLE

Catalog Number 328411

Device Problem Unintended Movement (3026)

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

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd insulin syringe with the bd ultra-fine¿ needle plunger rod moves out of barrel on its own.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 7072878.Investigation summary: customer returned (1) loose 1cc, 12.7mm syringe.Customer states that that plunger rod moves out of barrel on its own.The returned syringe was examined and no defects were observed on the sample.The sample was tested and was able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 7072878.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200689255] noted that did not pertain to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7348634
• MDR Text Key: 102864266
• Report Number: 1920898-2018-00157
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328411
• Device Lot Number: 7072878
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 03/07/2018
• Supplement Dates FDA Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other