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 Patient Involvement (2645)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).
Event or Problem Description
It was reported during use the bd syringe 0.5ml 30ga 8mm had foreign matter on the device/cannula /in fluid path.The following information was provided by the initial reporter: the consumer found a small amount of liquid on the tip of his needle when he depressed the plunger rod.
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: 8/19/2020.H.6.Investigation: customer returned (1) loose 1/2cc, 8mm syringe.Customer states that they found a small amount of liquid on the tip of his needle when he depressed the plunger rod.The returned syringe was tested and a small clear droplet of material came out of the cannula when the plunger rod was fully depressed.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely silicone.Unable to perform dhr check for foreign matter on needle tip due to unknown lot number.Process summary: automatic syringe assembly machine, which feeds 0.5ml, syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Dhr, l2l dispatches, logbook entries could not be looked at as no lot number was given.Root cause for this defect cannot be determined.H3 other text : see h.10.
Event or Problem Description
It was reported during use the bd syringe 0.5ml 30ga 8mm had foreign matter on the device/cannula in fluid path.The following information was provided by the initial reporter: the consumer found a small amount of liquid on the tip of his needle when he depressed the plunger rod.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned as of 14 august 2020 therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform a dhr review for foreign matter on needle tip due to unknown lot number.H3 other text : see h.10.
Event or Problem Description
It was reported during use the bd syringe 0.5ml 30ga 8mm had foreign matter on the device/cannula /in fluid path.The following information was provided by the initial reporter: the consumer found a small amount of liquid on the tip of his needle when he depressed the plunger rod.

• 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: 10365009
• Report Number: 1920898-2020-00988
• Device Sequence Number: 16910644
• Product Code: FMI
• UDI-Device Identifier: 00311917025285
• UDI-Public: 00311917025285
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2020

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 Model Number: 928854
• Device Catalogue Number: 928854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 07/14/2020; 07/14/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 08/17/2020; 09/02/2020
• 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