MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD® ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number	305540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 1 of the bd® allergy syringe with permanently attached needle base was broken.Report 2 of 3.The following was provided by the initial reporter: verbatim: 1 with malformed plunger base are you able to identify the problem regarding to the ¿malformed plunger base¿? was it stopper defective? the stopper was fine- it was the base of the actual syringe that was broken was there any patient involvement? yes what was the patient outcome? no remarkable outcome was there any delay of, or change in, the course of treatment due to this event? no was there any leakage for the breakage issue? no are you able to provide the incident date for ¿malformed plunger base¿ and¿ break while aspirating¿? the base no, i remember injecting a patient and it caught me off guard once i had the proper grip.The break while aspirating happened on (b)(6) 2023.

• Brand Name: BD® ALLERGY SYRINGE WITH PERMANENTLY ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17221853
• Report Number: 1920898-2023-00408
• Device Sequence Number: 12528579
• Product Code: FMF
• UDI-Device Identifier: 00382903055401
• UDI-Public: 00382903055401
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/18/2023

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: Health Professional
• Device Catalogue Number: 305540
• Device Lot Number: 2101420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown