MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10ML S/T 200 S/C; PISTON SYRINGE

Catalog Number	303134
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 10ml s/t 200 s/c tip broke.The following information was provided by the initial reporter: material #:303134 batch#: unknown.Rcc received a complaint via email.Chc complaint reference #: (b)(4), hospital complaint reference #: (b)(4), customer (hospital) name: xxx, correspondence language: english, cat# of product being complained: (b)(4), description of product: syringe slip tip 10cc 200ea/bx 2bx/ca, lot or s/n: unknown, complaint category: damaged / broken, incident date: (b)(6) 2025, hospital complaint reference #: (b)(4).Details of complaint (reported issue): "a full 10ml was drawn out, and when the syringe was inserted into the side port again to check if extra fluid/air remained, the tip of the syringe broke off inside the port and could not be removed.Since the full 10ml had been drawn out and visualized, the foley was then removed with ease, and upon visible inspection, no fluid remained inside the balloon." additional information will be sent via separate email.Complaint noticed: during / after use problem frequency: 1st time customer exposure: patient injury: no has health canada been informed? unknown qty affected: 1 ea samples available? yes is customer requesting an rga? no return qty: qty samples: 1 ea.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported that the tip of the syringe broke off inside the port and could not be removed.To support the investigation, one fully assembled 10 ml luer-lok syringe was received for evaluation by the quality team.Upon inspection, it was observed that the entire collar at the top of the barrel was completely broken.However, based on the verbatim description and the evidence provided, this condition cannot be confirmed as originating from the manufacturing process.As a result, a potential root cause could not be identified, and no corrective actions are deemed necessary.

• Brand Name: BD SYRINGE 10ML S/T 200 S/C
• 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: 23366111
• Report Number: 1213809-2025-00670
• Device Sequence Number: 8879413
• Product Code: FMF
• UDI-Device Identifier: 00382903031344
• UDI-Public: (01)00382903031344
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• 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: Health Professional
• Device Catalogue Number: 303134
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown