MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 30GA 8MM; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	928855
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that during use the hub separated from device and stuck in shield with a bd syringe 0.3ml 30ga 8mm.The following information was provided by the initial reporter: consumer reported found several needle hub assembly stuck in shield.
Event or Problem Description
It was reported that during use the hub separated from device and stuck in shield with a bd syringe 0.3ml 30ga 8mm.The following information was provided by the initial reporter: consumer reported found several needle hub assembly stuck in shield.
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: 6/8/2020.H.6.Investigation: customer returned one (1) loose 0.3ml insulin syringe.Consumer reported found several needle hub assembly stuck in shield.The returned syringe was examined, and it was observed that the needle hub/shield assembly was separated from the syringe barrel; no damage to the barrel tip was observed.A review of the device history record was completed for batch# 9203941.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to this complaint.Process summary: automatic syringe assembly machine, which feeds 3/10cc, 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, and logbook entries were looked at, nothing pertaining to this defect was found.Root cause for this defect cannot be determined.Capa#1122103 was initiated.H3 other text : see h.10.

• Brand Name: BD SYRINGE 0.3ML 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: 10130924
• Report Number: 1920898-2020-00632
• Device Sequence Number: 2240247
• Product Code: FMI
• UDI-Device Identifier: 00311917025278
• UDI-Public: 00311917025278
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 06/17/2020

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: 928855
• Device Catalogue Number: 928855
• Device Lot Number: 9203941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 06/17/2020
• 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