SYRINGE 50-60 ML/L NO NEEDLE

Report

• Report Number: MW5154806
• Event Type: Malfunction
• Date Received: May 13, 2024
• Report Date: May 7, 2024
• Manufacturer: BECTON DICKINSON AND COMPANY
• Product Code: FMF
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: Yes

Narratives

Description of Event or Problem · 0

SPONTANEOUS. PT REPORTED THAT IS INFUSING RIGHT NOW, JUST STARTED TODAY. COMPLETED 60ML OUT OF 80ML. LAST SYRINGE FOUND THAT SYRINGE BLACK SPECKS, DOTS INSIDE, NOT FLOATING IN THE MEDICATION, THE INK REFLECTING THROUGHOUT THE SYRINGE. THE MANUFACTURER CONFIRMED DEFECTIVE SYRINGE ADVISING NOT TO USE DUE TO INSIDE OF SYRINGE SHOULD ONLY HAVE LUBRICANT AND NO INK. INKS SHOULD ONLY BE ON THE OUTSIDE OF THE SYRINGE. NO MISSED DOSE OR ADVERSE EVENTS REPORTED; UNKNOWN IF AVAILABLE FOR RETURN; UNKNOWN IF MD AWARE. NO FURTHER INFORMATION PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1547757	SYRINGE 50-60 ML/L NO NEEDLE	SYRINGE, PISTON	FMF	BECTON DICKINSON AND COMPANY		3275068

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female		EPINEPI-RINE AUTO-INJ| HIZENTRA 16 G

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Type of report · 1

• Initial submission