MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA; SYRINGE, ANTISTICK

Catalog Number	305270
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe integra 3ml w/ndl 25x1 rb caused leakage.Rcc received a complaint via email.I just used a bd integra syringe 3ml 25g 1" tw (0.5mm x 25mm) for cyanocobalamin (b-12) injection into my thigh, which i do monthly.I have been on b-12 since the 1990s.As i fully pushed it in, this syringe leaked between the upper part (needle) and the lower part (vial), spilling onto my hand and the carpet.I have no idea how much i went into my muscle.Maybe nothing! i tried to scan the qr code but was unable.(b)(4), lot 4304388.Crack: not that i can see loose connection: i'm not sure.
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 one sample of a 3 ml integra syringe, part number 305270, batch 4304388, was received and evaluated.The sample was received in an unsealed package containing all applicable product information.Leak testing was performed, and no leakage was observed, therefore, the sample was found acceptable.No additional defects were identified, and the observed condition meets product specifications.A device history record review was completed for material number 305270, lot 4304388.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and is compliant with applicable product specifications.

• Brand Name: BD INTEGRA
• Common Device Name: SYRINGE, ANTISTICK
• 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: 24455574
• Report Number: 1213809-2026-00091
• Device Sequence Number: 21369404
• Product Code: MEG
• UDI-Device Identifier: 00382903052707
• UDI-Public: (01)00382903052707(17)290930(10)4304388
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 305270
• Device Lot Number: 4304388
• 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: 02/01/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown