MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE; PISTON SYRINGE

Catalog Number	305950
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 10 bd allergy syringe trays with bd safety glide¿ needles had broken safety covers.This is 2 of 3 related reports.The following information was provided by the initial reporter: "customer had multiple complaints about batch 2283756.1) the syringe with catalogue number syr-80394 was faulty and defective, 2) there was an injury at the customers workplace with patients.This due to the syringes not being sharp enough or was not cut properly.The customer stated it was the allergy treated syringe.The customer also stated that the little piece that holds the safety guard/glid was sliding around before they would be able to manually push the lever, or the item would move before pushing it in.3) a total of 10 needles were discarded without the safety cover due to it being broken and the safety glid not being able to close.Something was blocking where it was supposed to slid.4) the customer stated that the syringe would draw up fine but then started to fly to loose.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17815643
• Report Number: 1920898-2023-00651
• Device Sequence Number: 16729959
• Product Code: FMF
• UDI-Device Identifier: 00382903059508
• UDI-Public: 00382903059508
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

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: Other
• Device Catalogue Number: 305950
• Device Lot Number: 2283756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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