MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ ALLERGY TREATMENT SYRINGE TRAY; ANTISTICK SYRINGE

Catalog Number	305950
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the safety on the bd safetyglide¿ allergy treatment syringe tray's broke.The following was received by the initial reporter: customer complaint ((b)(4) ): customer said that they found 2 bd insulin syringes within their safety syringe trays.This is the 1st complaint received from a customer for the same issue involving batch 2221315.As alk and bd currently have no quality agreement in please respond to the complaint with your investigation results as soon as possible.

• Brand Name: BD SAFETYGLIDE¿ ALLERGY TREATMENT SYRINGE TRAY
• Common Device Name: ANTISTICK 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17547183
• Report Number: 1920898-2023-00557
• Device Sequence Number: 15126942
• Product Code: MEG
• UDI-Device Identifier: 30382903059509
• UDI-Public: (01)30382903059509
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2023

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: Lay User/Patient
• Device Catalogue Number: 305950
• Device Lot Number: 2221315
• 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: 08/01/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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