MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE; PISTON SYRINGE

Catalog Number	309623
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 1ml s/t w/ndl 27x1/2 rb had a syringe needle connectivity issue.The following information was provided by the initial reporter: material#: 309623, batch#: 4303341.Rcc received a complaint via phone.Customer states that their case of syringes do not open or close.They ordered off of po: (b)(4).Customer is unsure if their customer has any product to return for investigation.Ref#: 309623.Lot#: unknown at the time of the call.Customer response received on 10-oct-2025.1.Can you please provide an exact date of event in format dd-mmm-yyyy? we noticed this issue last week, where the needles attached to these syringes do not attach properly/completely and that means the system is overpressurized/when expelling liquids the needles have a tendency to come off¿even when they are removed and the air in the needle is expressed beforehand.We noticed this issue on 29/09/2025.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation it was reported that needles were not attaching properly to the syringes.To support the investigation, three hundred ninety-six samples of 1ml luer slip syringes with 27g ½" needles attached from batch 4303341 were received for evaluation by the quality team.All samples arrived in sealed packaging with complete product information displayed on the top web.A visual inspection and functional testing were performed, and no abnormalities were observed.The samples were found to be acceptable according to product specifications.It is recommended that the needle be securely tightened onto the syringe prior to use.A review of the device history record was completed for material number 309623, batch 4303341.The review confirmed that all visual inspections were performed in accordance with requirements, and no quality notifications were identified related to the reported condition.The lot was inspected and accepted based on the inspection control plan, approved for shipment, and determined to be in compliance with product specification requirements.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23392309
• Report Number: 1213809-2025-00676
• Device Sequence Number: 21335995
• Product Code: FMF
• UDI-Device Identifier: 00382903096237
• UDI-Public: (01)00382903096237(11)241029(17)290930(10)4303341
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 309623
• Device Lot Number: 4303341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown