MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 28GA 1/2IN 10BAG 500CAS; PISTON SYRINGE

Model Number	329465
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the syringe 0.5ml 28ga 1/2in 10bag 500cas was unable/difficult to aspirate during use.The following information was provided by the initial reporter: customer's spouse called to inform of an incident where the customer was unable to draw insulin into the syringe and was unaware that insulin could not be drawn.After dinner, customer checked blood glucose levels to greater that 300 mg/dl.They tried to redraw with the syringe previously used and determined it was drawing insulin, water on anything.Spouse of consumer stated, her husband is doing fine now.Stated, his numbers went down to normal and she did not have to take him to a doctor.Stated, her husband was unable to draw insulin.1 syringe affected.
Event or Problem Description
It was reported that the syringe 0.5ml 28ga 1/2in 10bag 500cas was unable/difficult to aspirate during use.The following information was provided by the initial reporter: customer's spouse called to inform of an incident where the customer was unable to draw insulin into the syringe and was unaware that insulin could not be drawn.After dinner, customer checked blood glucose levels to greater that 300 mg/dl.They tried to redraw with the syringe previously used and determined it was drawing insulin, water on anything.Spouse of consumer stated, her husband is doing fine now.Stated, his numbers went down to normal and she did not have to take him to a doctor.Stated, her husband was unable to draw insulin 1 syringe affected.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-10-23.H6: investigation summary customer returned one (1) used 28gx12.7mm, 0.5ml bd insulin syringe from lot 8218749.Consumer reported unable to draw insulin.The returned syringe was examined, and it was observed that a material was near the tip of the cannula.The syringe was then tested for flow: the syringe was unable to draw properly.A wire test was then performed on this sample: the wire passed through the cannula, however, there was a small residue observed at the tip of the wire after being through the cannula, similar to the material near the tip of the cannula.Since the syringe was returned after use, it could not be determined whether this material was caused after use, or as a result of a manufacturing defect.A review of the device history record was completed for batch# 9252463.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

• Brand Name: SYRINGE 0.5ML 28GA 1/2IN 10BAG 500CAS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10690600
• Report Number: 1920898-2020-01424
• Device Sequence Number: 3281925
• Product Code: FMF
• UDI-Device Identifier: 30382903294658
• UDI-Public: 30382903294658
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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): 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: 329465
• Device Catalogue Number: 329465
• Device Lot Number: 8218749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other