SYRINGE 50 ML L/L NO NEDLE

Report

• Report Number: MW5104748
• Event Type: Malfunction
• Date Received: October 18, 2021
• Report Date: May 5, 2021
• Manufacturer: BECTON DICKINSON
• Product Code: FMF
• Product Problem: Yes
• Report Source: Voluntary report
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

SPONTANEOUS. PATIENT REPORTED WAS MIXING AND THE SYRINGE POPPED OFF WHEN INSERTING THE SECOND SYRINGE WITH 50ML . CASSETTE LOT NUMBER 3971696, EXPIRATION DATE 06/17/2025; SYRINGE LOT NUMBER 0339309, EXPIRATION DATE UNKNOWN. NO HARM TO PATIENT. NO INTERRUPTION IN THERAPY. UNKNOWN IF PRODUCT AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PT? NO; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? NO; DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES; WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; REPORTED TO (B)(6) BY PT/CAREGIVER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1550167	SYRINGE 50 ML L/L NO NEDLE	SYRINGE, PISTON	FMF	BECTON DICKINSON		0339309
1550168	CASSETTE	SET, I.V, FLUID TRANSFER	LHI	SMITHS MEDICAL ASD, INC.	UNK	3971696

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Product problems · 1

• Detachment of Device or Device Component

Type of report · 1

• Initial submission