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

Catalog Number	300865
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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
It was reported that the bd syringe 50ml ll plunger movement was difficult.The following information was provided by the initial reporter: it was reported that we have identified an issue with syringe 300865, a 50/60 ml luer-lock syringe for syringe pumps, which is covered by our contract with you for injections and infusions.Our anaesthesia team in the operating theatre has encountered issues when using it, as the pump issues an occlusion warning when administering the induction dose during anaesthesia via tci, and the flow rate rises to as high as 800 ml/hour.This has now occurred on several occasions with at least two different batches: lot no.2505127, lot no.2507114.Additional information provided: it was mentioned as several occasions.Could you please provide the date of event? approx from 11/3 to today.Has there been any patient impact (serious injury, medical intervention, change of treatment required)? no patient impact has been reported.But extra effort has been needed to secure that the patient get the correct amount of anaesthesia medication.What pump was being used? b.Braun space plus.Please clarify which date refers to which lot#(s).The problem has occurred on many occasions in several departments in our hospital.First time on (b)(6), i don't have any more detailed information about every time it happened.

• Brand Name: BD PLASTIPAK 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.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24844860
• Report Number: 3003152976-2026-00176
• Device Sequence Number: 9047225
• Product Code: FMF
• UDI-Device Identifier: 00382903008650
• UDI-Public: (01)00382903008650(11)250731(17)300630(10)2507114
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 05/05/2026

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: 2507114
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown