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

Catalog Number	309623
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
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 needle was broken, the following information was provided by the initial reporter: material #:309623 batch#:4303339, 5038159.Rcc received a complaint via email.5593248 - xxxx - defective component/device (dosing syringe).Xxxxx catalogue: 309623 syringe 1ml s/t w/ndl 27x1/2 rb lot number(s): 4303339,5038159.Takeda awareness date: 17 nov 2025.Date of occurrence: unknown.Complaint description: case manager spoke with patient.Patient reported dosing needle came apart, lot #4303339.Patient did not use thumb nail as nurse had indicated during training to assist with using the dosing needle.No further details were provided.Product: xxxxxxx country of origin: united states sample / photo availability: no sample or pictures provided.Ae: no ae reported patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.Inv due by: (b)(6) 2025 no further information provided.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.

• 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: 23815441
• Report Number: 1213809-2025-00782
• Device Sequence Number: 15804933
• Product Code: FMF
• UDI-Device Identifier: 00382903096237
• UDI-Public: (01)00382903096237(11)241029(17)290930(10)5038159
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 5038159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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