MAUDE Adverse Event Report: BECTON DICKINSON, S.A. Plastipak Luer-Lok; Syringe, Piston

Catalog Number	300865
Medical Device Problem Codes	Difficult to Flush (1251); Infusion or Flow Problem (2964); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.4.Applicable 510k numbers are k182589; k980987.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
The following information was provided by the initial reporter: failure to administer medication to the patient during surgery and connection to a syringe pump.When did the incident occur? during use.It was reported that after connecting a 50 ml syringe to a syringe pump and initiating norepinephrine infusion, a significant amount of air was detected in the syringe, preventing delivery of the drug to the patient during surgery.Additional information provided: response received on (b)(6) 2026 5:58 pm (b)(6).Was patient or user harmed? if yes, please explain no.

• Brand Name: Plastipak Luer-Lok
• Common Device Name: Syringe, Piston
• 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: 25634958
• Report Number: 3003152976-2026-00312
• Device Sequence Number: 9736279
• Product Code: FMF
• UDI-Device Identifier: 00382903008650
• UDI-Public: (01)00382903008650(11)251212(17)301130(10)2512046
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: See H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/10/2026

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: 300865
• Device Lot Number: 2512046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 06/30/2026; 08/21/2026; 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown