MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 0.5 ML BD ULTRA-FINE II INSULIN SYRINGE

Catalog Number 326725

Device Problem Missing Information (4053)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 2 0.5 ml bd ultra-fine" ii insulin syringes experienced missing label information.The following information was provided by the initial reporter: lot not match position.

Event Description

It was reported that 2 0.5 ml bd ultra-fine¿ ii insulin syringes experienced missing label information.The following information was provided by the initial reporter: lot not match position.

Manufacturer Narrative

H6: investigation summary: customer returned a number of images showing a number of shelf cartons for 0.5ml, 30 gauge, 8mm syringes from lot 0041321.One of the shelf cartons is missing the print for its lot number, manufacturing date, and expiration date.A review of the device history record was completed for batch# 0041321.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the images received, bd was able to confirm the customer¿s indicated failure of label information missing.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: 0.5 ML BD ULTRA-FINE II INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12285297
• MDR Text Key: 265368795
• Report Number: 1920898-2021-00865
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326725
• Device Lot Number: 0041321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1