MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 30GA 8MM; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	928854
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that there was liquid foreign matter inside the barrel with a bd syringe 0.5ml 30ga 8mm.This occurred on 7 occasions prior to use.The following information was provided by the initial reporter: it was reported that the customer noticed what she described as "water" inside barrel of syringes.Stated, it was a few drops on needle tip when she pushed on plunger rod.The syringes were not used for injection.
Additional Manufacturer Narrative
H.6 investigation: no samples (including photos) were returned as of 21 january 2020 therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform a dhr review due to an unknown lot number.Bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.
Event or Problem Description
It was reported that there was liquid foreign matter inside the barrel with a bd syringe 0.5ml 30ga 8mm.This occurred on 7 occasions prior to use.The following information was provided by the initial reporter: it was reported that the customer noticed what she described as "water" inside barrel of syringes.Stated, it was a few drops on needle tip when she pushed on plunger rod.The syringes were not used for injection.

• Brand Name: BD SYRINGE 0.5ML 30GA 8MM
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9545748
• Report Number: 1920898-2019-01516
• Device Sequence Number: 17057483
• Product Code: FMI
• UDI-Device Identifier: 00311917025285
• UDI-Public: 00311917025285
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K955235
• 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): 01/22/2020

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 Model Number: 928854
• Device Catalogue Number: 928854
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/23/2020
• 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