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

Model Number	928850
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.0202228.It was reported that consumer is not sure if she drew up and injected the correct amount of medication and might have taken too much.Verbatim: consumer reported was using a different size 3/10ml insulin syringe for allergy shot amount.02.She was given from pharmacy the 1ml super thin insulin syringe did not know where to draw to, drew down to 20 units.Thinks she might have taken too much now.Advised consumer to call her doctor or pharmacy to inform of proper use and items.
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 0202228.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.H3 other text: see h10.
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.0202228.It was reported that consumer is not sure if she drew up and injected the correct amount of medication and might have taken too much.Verbatim: consumer reported was using a different size 3/10ml insulin syringe for allergy shot amount.02.She was given from pharmacy the 1ml super thin insulin syringe did not know where to draw to, drew down to 20 units.Thinks she might have taken too much now.Advised consumer to call her doctor or pharmacy to inform of proper use and items.

• Brand Name: SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10892803
• Report Number: 1920898-2020-01620
• Device Sequence Number: 13810294
• Product Code: FMF
• UDI-Device Identifier: 00311917014876
• UDI-Public: 00311917014876
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (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): 01/28/2021

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: 07/31/2025
• Device Model Number: 928850
• Device Catalogue Number: 928850
• Device Lot Number: 0202228
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1