MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

Catalog Number 324911

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problems Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is 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.

Event Description

T was reported that when taking injection some of the insulin leaks out and numbers have been low from not receiving all of dosage while using bd veo¿ insulin syringes with bd ultra-fine¿ needle.No serious injury reported.The following information was provided by the initial reporter: consumer reported when taking injection, some of the insulin leaks out.Stated, his numbers have been low because he is not getting all of his insulin.

Manufacturer Narrative

H.6.Investigation summary: a complaint lot history check was performed on lot # 2031598 for leakage and glucose level.This is the 1st.Related complaint for leakage and glucose level on lot # 2031598.No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.A review of the device history record was completed for batch# 2031598.All inspections and challenges were performed per the applicable operations qc specification.There were zero (0) notifications noted that did not pertain to the complaint.Embecta was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time.

Event Description

It was reported that when taking injection some of the insulin leaks out and numbers have been low from not receiving all of dosage while using bd veo¿ insulin syringes with bd ultra-fine¿ needle.No serious injury reported.The following information was provided by the initial reporter: consumer reported when taking injection, some of the insulin leaks out.Stated, his numbers have been low because he is not getting all of his insulin.

• Brand Name: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• 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 ; 8015296192
• MDR Report Key: 15192329
• MDR Text Key: 304960535
• Report Number: 1920898-2022-00531
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324911
• Device Lot Number: 2031598
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2022
• 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