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

Catalog Number 326725

Device Problem Missing Information (4053)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

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 the bd ultra-fine¿ ii short needle insulin syringe label information was missing.The following was reported by the initial reporter: no vendor lot.

Manufacturer Narrative

H6: investigation summary: no samples were returned therefore the investigation was performed based on the photo provided.The customer returned one photo of the 30gx8mm bd shelf carton.The customer reported no lot number.The photo was examined, and it was observed that the lot number, manufacturing date, and expiration date is missing from the shelf carton.A review of the device history record was completed for batch# 2332979.All inspections and challenges were performed per the applicable operations qc specifications.Based on the photo received, embecta was able to confirm the customer¿s indicated failure (label information missing).A definitive root cause cannot be determined.

Event Description

It was reported that the bd ultra-fine¿ ii short needle insulin syringe label information was missing.The following was reported by the initial reporter: no vendor lot.

• Brand Name: BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE
• 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: 17234668
• MDR Text Key: 318236520
• Report Number: 1920898-2023-00412
• Device Sequence Number: 1
• Product Code: FMF
• 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,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326725
• Device Lot Number: 2332979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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