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

Catalog Number 328466

Device Problems Air Leak (1008); Unintended Movement (3026)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 during use of the bd insulin syringe with the bd ultra-fine¿ needle the plunger moves on its own.The consumer stated ¿recently finding a lot of bubbles when drawing insulin and plunger moves on its own.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation results: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 7240961.All inspections and challenges were performed per the applicable operations qc specifications.There were five (5) notifications [200709755, 200710155, 200709218, 200713390, 200712699] noted that did not pertain to the complaint.Severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint for air bubbles and the 1st related complaint for unable to perform function (plunger movement) on lot # 7240961.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.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.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7388311
• MDR Text Key: 104263714
• Report Number: 1920898-2018-00218
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908466035
• UDI-Public: 00382908466035
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328466
• Device Lot Number: 7240961
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other