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

Model Number 328440

Device Problem Leak/Splash (1354)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insulin syringe with the bd ultra-fine¿ needle hub separated.This occurred on 2 occasions during use.The following information was provided by the initial reporter: material no.328440 batch no.9112704 it was reported that needle hub separated into needle shield on 2 syringes.Verbatim: consumer reported needle hub separated and stayed inside the shield, two syringes involved.Consumer does not re-use.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned as of 13 january 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9112704.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were three (3) notifications [200821671, 200821662, 200821922] noted that did not pertain to the complaint.

Event Description

It was reported that bd insulin syringe with the bd ultra-fine¿ needle hub separated.This occurred on 2 occasions during use.The following information was provided by the initial reporter: material no.328440 batch no.9112704 it was reported that needle hub separated into needle shield on 2 syringes.Verbatim: consumer reported needle hub separated and stayed inside the shield, two syringes involved.Consumer does not re-use.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9526310
• MDR Text Key: 193651973
• Report Number: 1920898-2019-01475
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908440035
• UDI-Public: 00382908440035
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328440
• Device Catalogue Number: 328440
• Device Lot Number: 9112704
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other