MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 28GA 1/2IN 10BAG 500 BDD; PISTON SYRINGE

Model Number	329410
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: level b investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for difficult unable to operate (not drawing) and needle clog on lot # 0034135.A review of risk management (b)(4) revision 13 indicates that the potential risk of this specific reported incident (syringe, difficult/unable to operate (not drawing, needle clog) was captured and addressed.Investigation summary: no samples were returned therefore the complaint could not be confirmed.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# 0034135.All inspections were performed per the applicable operations qc specifications.There was one (1) notification (b)(4) noted for insufficient barrel lube.Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.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.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that syringe 1.0ml 28ga 1/2in 10bag 500 bdd was unable to draw up insulin during use.The following information was provided by the initial reporter: material no.329410 batch no.0034135.It was reported that she is unable to draw up insulin in some syringes.Sometimes the needles are clogged and not release insulin once it's drawn.

• Brand Name: SYRINGE 1.0ML 28GA 1/2IN 10BAG 500 BDD
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10341934
• Report Number: 1920898-2020-00960
• Device Sequence Number: 14177716
• Product Code: FMF
• UDI-Device Identifier: 30382903294108
• UDI-Public: 30382903294108
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2025
• Device Model Number: 329410
• Device Catalogue Number: 329410
• Device Lot Number: 0034135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 07/29/2020
• 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