MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 30GA 8MM 10BAG 500CAS AP; PISTON SYRINGE

Catalog Number 328818

Device Problem Illegible Information (4050)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported 48 syringe 1.0 ml 30 ga 8 mm 10 bag 500 cas ap had label printing issues.The following information was provided by the initial reporter: "duplicate lot = 27 sp duplicate lot = 21 sp".

Manufacturer Narrative

Investigation summary: customer returned a number of images of shelf cartons for 1ml, 30 gauge, 8mm from lot 0097121.Multiple shelf cartons are crumpled or torn, with one shelf carton being entirely torn open.In addition, multiple cartons feature misprinted information, with overlapping text or text stretched out over an unintended location.A review of the device history record was completed for batch# 0097121.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 printing defects on the cartons.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.

Event Description

It was reported 48 syringe 1.0ml 30ga 8mm 10bag 500cas ap had label printing issues.The following information was provided by the initial reporter: "duplicate lot = 27 sp duplicate lot = 21 sp".

• Brand Name: SYRINGE 1.0ML 30GA 8MM 10BAG 500CAS AP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12291475
• MDR Text Key: 265576495
• Report Number: 1920898-2021-00871
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

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: 328818
• Device Lot Number: 0097121
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1