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	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the syringe 0.5ml 30ga 8mm 10bag 500 pl/wg experienced hub separation from the device during use.The following information was provided by the initial reporter: material no:928854 , batch no: 9161958.Consumer reported one syringe would be number 6 syringe from box removed shield and needle assemble removed with shield on (b)(6) 2020.
Event or Problem Description
It was reported that the syringe 0.5ml 30ga 8mm 10bag 500 pl/wg experienced hub separation from the device during use.The following information was provided by the initial reporter: material no:928854 batch no: 9161958.Consumer reported one syringe would be number 6 syringe from box removed shield and needle assemble removed with shield on (b)(6) 2020.
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 6/29/2020.Investigation: customer returned one (1) 0.5ml insulin syringe from an open polybag from lot 9161958.Consumer reported that needle shields were difficult to remove and one needle assembly detached with 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# 9161958.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 1/2cc, 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.Root cause for this defect cannot be determined.Dhr, l2l dispatches, logbook entries were looked at, nothing was found pertaining to this defect.

• 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: 10187911
• Report Number: 1920898-2020-00727
• Device Sequence Number: 16671206
• Product Code: FMI
• UDI-Device Identifier: 00311917025285
• UDI-Public: 00311917025285
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/08/2020

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: 9161958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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