MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 30GA 8MM; PISTON SYRINGE

Catalog Number 326702

Device Problem Missing Information (4053)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (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 1 bd syringe 1.0 ml 30 ga 8 mm had a label information issue.The following information was provided by the initial reporter : no lot number.

Manufacturer Narrative

H6: investigation summary: customer returned several images of a shelf carton for 1.0ml, 30 gauge, 8mm syringes from lot 0301994.The text for the lot number, manufacturing date, and expiration date is missing.A review of the device history record was completed for batch# 0301994.All inspections 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 missing label information.H3 other text : see h10.

Event Description

It was reported that 1 bd syringe 1.0ml 30ga 8mm had a label information issue.The following information was provided by the initial reporter: no lot number,.

• Brand Name: SYRINGE 1.0ML 30GA 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12368130
• MDR Text Key: 268215424
• Report Number: 1920898-2021-00931
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326702
• Device Lot Number: 0301994
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1