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

Catalog Number 320840

Device Problem Inaccurate Information (4051)

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

Event Date 03/09/2023

Event Type  malfunction  

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 10 bd micro-fine¿+ insulin syringes had misaligned scale markings.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from italian: "i wanted to inform you that lately i have noticed that the syringes do not have a perfect alignment of the dosing grid, which results in an increase of 1/2 unit, if not ,1 of the dose needed.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-apr-2023.H6: investigation summary: customer returned one shelf carton from lot# 2006761 with (10) 0.3ml x 31g x 8mm syringes inside.Customer reported that, i have noticed that the syringes do not have a perfect alignment of the dosing grid, which results in an increase of 1/2 unit, if not ,1 of the dose needed.The returned syringes were visually examined and observed no issues.The syringe was inspected via gauge to ensure correct placement of the graduation markings and observed the return samples found to be within permitted specifications.Functionality test was performed and observed no issues.No damage to the needles of any kind was observed and all functioned as intended.Hence, the reported issue could not be confirmed based on the samples return for investigation.A review of the device history record was completed for batch # 2006761 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the sample received, embecta was not able to confirm the customer indicated failure.The root cause could not be determined because the issue could not be confirmed.

Event Description

It was reported that 10 bd micro-fine¿+ insulin syringes had misaligned scale markings.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from italian: "i wanted to inform you that lately i have noticed that the syringes do not have a perfect alignment of the dosing grid, which results in an increase of 1/2 unit, if not ,1 of the dose needed.".

• Brand Name: BD MICRO-FINE¿+ 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: 16640534
• MDR Text Key: 312286910
• Report Number: 1920898-2023-00175
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

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: Lay User/Patient
• Device Catalogue Number: 320840
• Device Lot Number: 2006761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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