SYRINGE 50-60ML L/L NO NEEDLE

Report

• Report Number: MW5163603
• Event Type: Malfunction
• Date Received: December 12, 2024
• Date of Event: December 9, 2024
• Report Date: December 9, 2024
• Manufacturer: BECTON DICKINSON & 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

INDICATION: NONFAMILIAL HYPOGAMMAGLOBULINEMIA, IMMUNODEFICIENCY, UNSPECIFIED, AND SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN G[IGG] SUBCLASSES. STRENGTH/DOSE/FREQUENCY: USE AS DIRECTED TO ADMINISTER HIZENTRA (INFUSE 14GM (70ML) SUBCUTANEOUSLY EVERY WEEK). PATIENT REPORTED THAT ON (B)(6) 2024 ONE OF THE 50 ML BECTON DICKINSON SYRINGES HAD A CRACK AND PATIENT LOST HIZENTRA THAT WAS TRANSFERRED. PATIENT LOST MEDICATION FROM 2 OF THE 4 GM SYRINGES AND FROM 1 OF THE 2GM SYRINGES. PATIENT SAID THERE WERE 2 LOT NUMBERS ON THE PACKAGE 4213208 AND 4213235. PATIENT MISSED A DOSE; NO ADVERSE EVENT REPORTED; UNKNOWN IF SYRINGE(S] AVAILABLE FOR RETURN; UNKNOWN IF MD AWARE. REPORTED TO (B)(6) BY PT/CAREGIVER. REF REPORT: MW5163604.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
291911	SYRINGE 50-60ML L/L NO NEEDLE	SYRINGE, PISTON	FMF	BECTON DICKINSON & COMPANY		4213208

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR	Female		HIZENTRA 20% PFS (2GM TOTAL)| HIZENTRA 20% PFS (4GM TOTAL)

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Type of report · 1

• Initial submission