MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928857
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st.Related complaint for needle hub separates & does not detach as intended on lot # 0006836.A review of risk management document (b)(4) indicates that the potential risk of this specific reported incident (insulin syringe, needle hub separates, does not detach as intended) was captured and addressed.Investigation summary: no samples 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# 0006836.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.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 an unspecified number of syringe 0.5ml 31ga 8mm 10bag 500 pl/wg experienced hub separation from the device during use.The following information date received for intake: 29-sep-2020.Consumer reported needle hub separated and stayed inside of shield needle shield difficult to remove.Lot #: 0006836.Catalog #: 928857.Date of event: (b)(6) 2020.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/23/2020.H.6.Investigation: customer returned (1) 1/2cc, 8mm, 31g walgreens syringe in an open poly bag from lot # 0006836.Customer states that the needle hub separated and stayed inside the shield and the shield was difficult to remove.The returned syringe was tested to determine the shield removal force.The shield removal force was measured as 3.61 lbs., which falls within specifications.Also the hub assembly did not separate from the barrel when the shield was removed.A review of the device history record was completed for batch# 0006836.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that an unspecified number of syringe 0.5ml 31ga 8mm 10bag 500 pl/wg experienced hub separation from the device during use.The following information date received for intake: 29-sep-2020 consumer reported needle hub separated and stayed inside of shield needle shield difficult to remove.Lot #: 0006836, catalog #: 928857, date of event: 09-28-20.

• Brand Name: SYRINGE 0.5ML 31GA 8MM 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: 10714745
• Report Number: 1920898-2020-01443
• Device Sequence Number: 16942927
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/11/2020

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: Lay User/Patient
• Device Expiration Date: 01/31/2025
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: 0006836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1