MAUDE Adverse Event Report: BECTON DICKINSON, S.A. LUER-LOK; PISTON SYRINGE

Catalog Number	302995
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4).Follow up report for correction.Mfr report # 1213809-2026-00145 was filed as the site legal name was incorrectly reported as san agustin in the initial mdr submission, 3003152976-2026-00139.Mfr report # 1213809-2026-00145 was submitted to update the site legal name to canaan, and to have the proper mfr number.
Event or Problem Description
It was reported that bd syringe 10 ml ll s/c 200 had leakage past the stopper.Verbatim: pharmacy has reported four incidents where blood has leaked out the back of the syringe, past the plunger.These syringes are used by pharmacy to prepare heparin 9,000 u/9 ml, which is then sent out for teams to flush hd lines.Additional information received on 26-feb-2026: the manufacture number for the syringe is 302995.We unfortunately do not have a lot number to provide or even the defective product to return.Teams threw it away before reaching out to us.If we continue to have issues, i have asked teams to retain the syringes for further investigation.I did follow up with the unit that originally submitted the complaint, and they advised they do have four syringes that could be shipped back for investigation if we are provided with a shipping label.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24640785
• Report Number: 3003152976-2026-00139
• Device Sequence Number: 9842408
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: (01)00382903029952
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: Health Professional
• Device Catalogue Number: 302995
• Device Lot Number: UNKNOWN
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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