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	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd allergy syringe tray with bd safetyglide¿ needle experienced scale marking issues.With lot numbers 2304576 and 2251991.The following information was provided by the initial reporter: some without numbering so far 15 of them.
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 2304576 d.4.Medical device expiration date: 30-nov-2027 h.4.Device manufacture date: 31-oct-2022 d.4.Medical device lot #: 2251991 d.4.Medical device expiration date: 30-sept-2027 h.4.Device manufacture date: 08-sept-2022.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
No additional information.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir 10000690801.This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: safetyglide-allergy.Device failure: scale marking issue.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17552458
• Report Number: 1920898-2023-00560
• Device Sequence Number: 15169307
• Product Code: MEG
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: SEE H.10
• 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
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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