MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA 8MM 10BAG 500 PL/WG; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	928854
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.Review of the device history record was completed for batch# 9161958.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to this complaint.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.Root cause: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported before use the syringe 0.5ml 30ga 8mm 10bag 500 pl/wg was found with no label or missing label information or illegible (all packaging levels).The following information was provided by the initial reporter: pharmacist reported the expiration date was missing from the box.

• Brand Name: SYRINGE 0.5ML 30GA 8MM 10BAG 500 PL/WG
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10045750
• Report Number: 1920898-2020-00498
• Device Sequence Number: 14149038
• Product Code: FMI
• UDI-Device Identifier: 00311917025285
• UDI-Public: 00311917025285
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K955235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: Health Professional
• Device Model Number: 928854
• Device Catalogue Number: 928854
• Device Lot Number: 9161958
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/11/2020
• 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