FDA Adverse Event Malfunction Summary report: N

BD PLASTIPAK LUER-LOK

MDR report key: 24678051 · Received March 24, 2026

Report

Report Number: 3003152976-2026-00147
Event Type: Malfunction
Date Received: March 24, 2026
Date of Event: March 11, 2026
Report Date: March 24, 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: FR
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. THIS REPORT IS SUPPLEMENTAL TO PREVIOUSLY SUBMITTED 2243072-2026-00218. IT WAS DETERMINED THAT THE LEGAL MANUFACTURER IS SAN AGUSTIN. THIS NEW MDR IS BEING SUBMITTED TO CORRECT THE LEGAL SITE AND TO SUBMIT A MDR UNDER THE CORRECT SITE REGISTRATION NUMBER. A CORRECTION SUPPLEMENTAL WAS SUBMITTED FOR 2243072-2026-00218.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE BD SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT # 251101 IT WAS REPORTED THAT MEDICATION PREPARATION BY A REGISTERED NURSE: DIFFICULTY DRAWING UP A SYRINGE OF HOC FROM A BOTTLE OF SALINE SOLUTION. NEEDLE CHANGED, SAME PROBLEM. ULTIMATELY, SALINE DRAWN INTO A 50 ML SYRINGE: DISCOVERY OF A PLASTIC ¿CARROT¿ IN THE SYRINGE. SYRINGE RETAINED AND ONE NEEDLE FROM THE SAME BATCH COLLECTED FOR MEDICAL DEVICE SURVEILLANCE. PROVEN CONSEQUENCES: PLASTIC IN A SYRINGE (SEE PHOTO): MAJOR RISK TO THE PATIENT WASTED TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
275566	BD PLASTIPAK LUER-LOK	PISTON SYRINGE	FMF	BECTON DICKINSON, S.A.		UNKNOWN	00382903008650

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown