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	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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 #4303339.Verbatim: rcc received a complaint via email.Email(s) attached.Contact name: contact number: contact email (if available): n/a.Item(s): 309623.Lot(s):4303339.Date incident occurred: on going.Was the patient impacted? yes.If yes, describe: when taking cap off needle comes apart is a sample available? yes.Customer request? replacement.Additional information provided: customer said that the needle hub is coming loose and disconnecting from the syringe customer also said that her dr had mentioned other pts having the same issue, i called the office and spoke with a clinician who said they were going to confirm if this is in fact true.She will be emailing us back with this pr in the subject.610-366-1366.Dr (b)(6).
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported that when the cap was removed, the needle detached from the syringe.To support the investigation, two samples of 1ml luer slip syringes with 27g ½" needles from lot 4303339 were received for evaluation by the quality team.Both samples arrived in sealed packaging.One sample exhibited no defects or imperfections, while the other experienced needle detachment when the shield was removed, consistent with a tight shield condition.This tight shield is non-conforming to product specifications and is linked to the assembly process.A device history record review was conducted for material number 309623, lot 4303339.The review confirmed that all visual inspections were performed according to requirements, with no quality notifications related to the reported condition.The lot was inspected and accepted based on the inspection control plan and subsequently approved for shipment.The event is associated with a known issue affecting this machine during the timeframe in which the lot was manufactured.As a corrective action, a quality alert addressing tight shields was issued to the plant.

• 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: 23577477
• Report Number: 1213809-2025-00720
• Device Sequence Number: 9223231
• Product Code: FMF
• UDI-Device Identifier: 00382903096237
• UDI-Public: (01)00382903096237(11)241029(17)290930(10)4303339
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2025

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: Lay User/Patient
• Device Catalogue Number: 309623
• Device Lot Number: 4303339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 12/06/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/08/2025
• 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