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

Catalog Number 328418

Device Problem Leak/Splash (1354)

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

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 bd ultra-fine needle stopper separated from the plunger rod.Other syringes were difficult to move the plunger rod.No serious injury or medical intervention was reported.

Event Description

It was reported that bd insulin syringe with bd ultra-fine¿ needle stopper separated from the plunger rod.Other syringes were difficult to move the plunger rod.No serious injury or medical intervention was reported.

Manufacturer Narrative

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# 7353798.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Severity ranking is s1.A complaint history check was performed and this is the 1st related complaint for stopper separates and plunger rod difficult to move on lot # 7353798.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: 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.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: BD INSULIN SYRINGE WITH 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: 8206796
• MDR Text Key: 131774256
• Report Number: 1920898-2018-00985
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 328418
• Device Lot Number: 7353798
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other