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

Catalog Number 328466

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Hypoglycemia (1912)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

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 2 of the bd insulin syringes with bd ultra-fine¿ needle scale marking issues resulting her having a insulin reaction.The following information was provided by the initial reporter: consumer reported caller found a syringe with scale markings off by 1/2 to 1 unit she feels.Resulting her having a insulin reaction.

Manufacturer Narrative

H6: investigation summary; no samples 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# 2087113.All inspections and challenges were performed per the applicable operations qc specification.H3 other text : see h10.

Event Description

It was reported that 2 of the bd insulin syringes with bd ultra-fine¿ needle scale marking issues resulting her having a insulin reaction.The following information was provided by the initial reporter: consumer reported caller found a syringe with scale markings off by 1/2 to 1unit she feels.Resulting her having a insulin reaction.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16691740
• MDR Text Key: 312804091
• Report Number: 1920898-2023-00198
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• 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: 2087113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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