MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE; PISTON SYRINGE

Model Number	324912
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 the shield separated from the bd veo¿ insulin syringe with the bd ultra-fine¿ needle in the packaging, and 2 syringes' needles broke off in the injection site and were removed with tweezers.The following information was provided by the initial reporter: "consumer reported that one needle was unshielded and sticking through the bag, the shield was loose inside of the bag." "consumer also reported that 2 needles broke off in the injection site during injection.She was able to remove the needles with a tweezer, no medical attention, no injuries.".

• Brand Name: BD VEO INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12610417
• Report Number: 1920898-2021-01065
• Device Sequence Number: 11116383
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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 Expiration Date: 09/30/2025
• Device Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 0252919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1