MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 326638

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 while using bd ultra-fine¿ ii 3/10ml insulin syringe the cannula was too long, and there was a mix of products.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the user reported that needles longer than the standard were mixed in.

Event Description

It was reported while using bd ultra-fine¿ ii 3/10ml insulin syringe the cannula was too long, and there was a mix of products.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the user reported that needles longer than the standard were mixed in.

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# 2031535.All inspections and challenges were performed per the applicable operations qc specification.H3 other text : see h10.

• Brand Name: BD ULTRA-FINE¿ II 3/10ML 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16751571
• MDR Text Key: 313412135
• Report Number: 1920898-2023-00231
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903266388
• UDI-Public: (01)00382903266388
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326638
• Device Lot Number: 2031535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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