MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA; PISTON SYRINGE

Catalog Number	329408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that separation occurred during use with a syringe 0.5ml 31ga no ins.The following information was provided by the initial reporter, "item# :329408, lot #: 8316516.Found 1 syringe when removed shield, metal needle came off syringe.No plastic part with it just metal.Consumer thinks its laying inside the needle shield.Denied reusing.Has poor vision.".
Additional Manufacturer Narrative
Investigation: customer returned one (1) loose 31g x 8mm, 0.5ml bd insulin syringe from lot 8316516.Consumer reported found 1 syringe when remove shield metal needle came off syringe, no plastic part with it just metal; consumer thinks its laying inside the needle shield.The returned sample was examined, and it was observed that the needle-hub/shield assembly was separated from the barrel; no damage to the barrel tip was observed.No other issues were observed on the returned sample.A review of the device history record was completed for batch# 8316516.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted that did not pertain to the 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.Dispatch 45914 was entered for raised shields during the production of this batch.The issue was resolved by cleaning off the photo eye that looks for raised shields.This batch was produced before acr19-04-007 and scr19-04-003 which addressed raised needle assemblies by replacing the sensor eyes with cameras for more accurate measurement of raised needle assemblies.
Event or Problem Description
It was reported that separation occurred during use with a syringe 0.5ml 31ga no ins.The following information was provided by the initial reporter, "item 329408 lot # 8316516 d found 1 syringe when removed shield, metal needle came off syringe.No plastic part with it just metal.Consumer thinks its laying inside the needle shield.Denied reusing.Has poor vision.".

• Brand Name: SYRINGE 0.5ML 31GA
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8907932
• Report Number: 1920898-2019-00841
• Device Sequence Number: 11262632
• Product Code: FMF
• UDI-Device Identifier: 00382903294084
• UDI-Public: 00382903294084
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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): 09/10/2019

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 329408
• Device Lot Number: 8316516
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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