MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 324903

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

It was reported that the bd ultra-fine¿ insulin syringe with sterile interior experienced foreign matter in fluid path.The following information was provided by the initial reporter: the customer stated that after injecting the drug into the syringe, the customer found a orange fm on the inner wall of the syringe.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary customer returned (1) loose 1cc, 6mm syringe without any packaging.Customer states that they found an orange fm on the inner wall of the syringe.The syringe was returned with approximately 40 units of a clear liquid inside the barrel.The sample was visually examined and exhibited a loose, orange piece of material floating in the clear liquid in the barrel.The liquid was subsequently removed from the barrel.The orange piece of material was also removed from the barrel.This piece was measured with a ruler and found to be slightly longer than 2 mm and about 0.5 mm wide.This material was prepared for ftir spectral analysis by flattening the material.The ftir spectral analysis shows that this material is most likely polyethylene mixed with some silicone.A review of the device history record was completed for batch# 2199495.All inspections were performed per the applicable operations qc specifications.Embecta was able to duplicate or confirm the customer¿s indicated failure.

Event Description

It was reported that the bd ultra-fine¿ insulin syringe with sterile interior experienced foreign matter in fluid path.The following information was provided by the initial reporter: the customer stated that after injecting the drug into the syringe, the customer found a orange fm on the inner wall of the syringe.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE WITH STERILE INTERIOR
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 16502860
• MDR Text Key: 310961180
• Report Number: 1920898-2023-00100
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/09/2023

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: 324903
• Device Lot Number: 2199495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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