FDA Adverse Event Malfunction Summary report: N

BD PLASTIPAK LUER-LOK

MDR report key: 24840761 · Received April 10, 2026

Report

Report Number: 3003152976-2026-00177
Event Type: Malfunction
Date Received: April 10, 2026
Date of Event: March 23, 2026
Report Date: March 27, 2026
Manufacturer: BECTON DICKINSON, S.A.
Product Code: FMF
UDI-DI: 00382903008650
PMA / PMN Number: SEE H.11
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SW
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE BD SYRINGE 50ML LL PLUNGER MOVEMENT WAS DIFFICULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECORD OPENED IN REFERENCE TO RESPONSE FROM (B)(4). PER ORIGINAL COMMUNICATION: 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. PER RESPONSE ON 23MAR2026: 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 ANASTESIA MEDICATION. WHAT PUMP WAS BEING USED? B. BRAUN SPACE PLUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
481976	BD PLASTIPAK LUER-LOK	PISTON SYRINGE	FMF	BECTON DICKINSON, S.A.		UNKNOWN	00382903008650

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown