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

Catalog Number 328818

Device Problem Component Missing (2306)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter addr 1: (b)(6).H3.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 bd ultra-fine¿ ii short needle insulin syringe was missing the cover that lead to a clean needle stick.The following information was provided by the initial reporter: customer called to informed consumer went to their store to buy the below item however once they open the box, consumer accidentally stung as there is no cap (cover) the needle.

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# 1074356.All inspections and challenges were performed per the applicable operations qc specification.

Event Description

It was reported that 2 bd ultra-fine¿ ii short needle insulin syringe was missing the cover that lead to a clean needle stick.The following information was provided by the initial reporter: customer called to informed consumer went to their store to buy the below item however once they open the box, consumer accidentally stung as there is no cap (cover) the needle.

• Brand Name: BD ULTRA-FINE¿ II SHORT NEEDLE 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16773337
• MDR Text Key: 313947626
• Report Number: 1920898-2023-00241
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328818
• Device Lot Number: 1074356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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