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

Model Number	928850
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Codes	No Information (3190); Insufficient Information (4580)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10813256
• Report Number: 1920898-2020-01542
• Device Sequence Number: 14535317
• Product Code: FMF
• UDI-Device Identifier: 00311917014876
• UDI-Public: 00311917014876
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2025
• Device Model Number: 928850
• Device Catalogue Number: 928850
• Device Lot Number: 0006070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1