MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE VET SYRINGE 0.3ML X 29G X 12.7MM 10 BAG

Model Number	323000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 does not detach as intended, needle hub separates and needle stick (clean) on lot # 9266921.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, shield does not detach as intended, needle hub separates, needle stick) was captured and addressed investigation summary: no samples (including photos) 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 # 9266921 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200879125] 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 during use the vet syringe 0.3ml x 29g x 12.7mm 10 bag experienced shield/cap does not attach/detach and needlestick injury - self.The following information was provided by the initial reporter: the customer stated that with four syringes it was hard to remove shields and the needle hub assembly separated when removed.Also reported, on one of these syringes she pulled hard and needle stuck her finger.No medical attention sought.

• Brand Name: VET SYRINGE 0.3ML X 29G X 12.7MM 10 BAG
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10434288
• Report Number: 1920898-2020-01104
• Device Sequence Number: 11773307
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

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: 10/31/2024
• Device Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 9266921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/20/2020
• 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