MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 324910

Device Problem Leak/Splash (1354)

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

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation: customer returned (1) loose 3/10cc 6mm 31g bd veo insulin syringe.Customer states the plunger rod was difficult to move during injection.The returned syringe was examined and when trying to draw the plunger back, it did not feel difficult to move.The alleged issue could not be confirmed.A review of the device history record was completed for batch# 7317969.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted for deformed stopper/dry barrel.There were four (4) notifications [(b)(4)] 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.

Event Description

It was reported with the use of the bd¿ insulin syringe there was an issue with plunger rod difficult to move during injection.

• Brand Name: BD¿ INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8197858
• MDR Text Key: 131594069
• Report Number: 1920898-2018-00953
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249107
• UDI-Public: 00382903249107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 324910
• Device Lot Number: 7317969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other