MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928852
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	06/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: level b investigation: - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_3__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle stick (after use/dirty) and cannula through shield on lot # 9203872.A review of risk management (b)(4) revision 13 indicates that the potential risk of this specific reported incident (syringe, needle stick (after use/dirty) and cannula through shield) was captured and addressed appropriately.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# 9203872.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that did not pertain 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 0.3ml 29ga 1/2in 10bag 500 pl/wg experienced needle through shield after recapping and resulted in the device user receiving an unspecified number of needle stick injuries.Product defects occurred during use.No medical testing/intervention was sought/received as a result of the dirty needle stick(s).The following information was provided by the initial reporter: material no:928852 batch no: 9203872.Pet owner stated, she stuck her finger as a result of re-shielding after her pets injection.Needle puncture the shield when she re-shielded.Did not seek medical.Suggested we make shields that are puncture proof.Explained to pet owner never to re-shield date of event: (b)(6) 2020.

• Brand Name: SYRINGE 0.3ML 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: 10160530
• Report Number: 1920898-2020-00689
• Device Sequence Number: 3610928
• Product Code: FMF
• UDI-Device Identifier: 00311917014920
• UDI-Public: 00311917014920
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• 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): 06/09/2020

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: 07/31/2024
• Device Model Number: 928852
• Device Catalogue Number: 928852
• Device Lot Number: 9203872
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/16/2020
• 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