MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG

Model Number 928850

Device Problem Volume Accuracy Problem (1675)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg had scale marking issues.The following information was provided by the initial reporter: material no:928850 batch no: 0006070.It was reported that the consumer asked to please note on the box that the scale is different than other insulin syringes.Verbatim: consumer reported was getting 1/2ml 29g misread the markings on this current purchase 1ml syringe.Used to drawing down to the first bold marker thinking it was 5 units.On this syringe its 10 units and could not see this.Asking please note on the box this scale is different then other insulin syringes.

Event Description

It was reported that syringe 1.0ml 29ga 1/2in 10bag 500 pl/wg had scale marking issues.The following information was provided by the initial reporter: material no:928850; batch no: 0006070.It was reported that the consumer asked to please note on the box that the scale is different than other insulin syringes.Verbatim: consumer reported was getting 1/2ml 29g misread the markings on this current purchase 1ml syringe.Used to drawing down to the first bold marker thinking it was 5 units.On this syringe its 10 units and could not see this.Asking please note on the box this scale is different then other insulin syringes.

Manufacturer Narrative

H6: investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 0006070.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

• Brand Name: SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10813256
• MDR Text Key: 216947419
• Report Number: 1920898-2020-01542
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917014876
• UDI-Public: 00311917014876
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 928850
• Device Catalogue Number: 928850
• Device Lot Number: 0006070
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1