MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR 0.3ML 0,25MM (31G) X 6MM; PISTON SYRINGE

Catalog Number 324900

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

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¿ insulin syringe with sterile interior 0.3ml 0,25mm (31g) x 6mm the lot was not printed properly.This occurred 200 times.There was no report of patient impact.The following information was provided by the initial reporter: poly bag torn and information not clear lot number printed on polybag shown to not be clear (incomplete printing) & bag shown to be cut / torn.

Event Description

It was reported while using bd ultra-fine¿ insulin syringe with sterile interior 0.3ml 0,25mm (31g) x 6mm the lot was not printed properly.This occurred 200 times.There was no report of patient impact.The following information was provided by the initial reporter: poly bag torn and information not clear.Lot number printed on polybag shown to not be clear (incomplete printing) & bag shown to be cut / torn.

Manufacturer Narrative

H6: investigation summary: no samples were returned therefore the investigation is performed based on the photos provided.The customer provided (4) photos of 0.5ml 30ga 8mm polybags, reporting packaging printing defect.The photos were visually examined and observed no issues related to printing defect.Based on the photos provided, embecta was not able to confirm the reported failure.A review of the device history record was completed for batch #2199394.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR 0.3ML 0,25MM (31G) X 6MM
• 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: 16782279
• MDR Text Key: 314007729
• Report Number: 1920898-2023-00246
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382904900014
• UDI-Public: (01)00382904900014
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 324900
• Device Lot Number: 2199394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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