N/A 4380Recalls & reported problems

Carefusion 2200, Inc · Economy Soft Tissue Biopsy Tray · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403108563), received between Nov 9, 2023 and Aug 1, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Contamination1

Patient problems

Needle Stick/Puncture1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AS THE HEALTH CARE PROVIDER (HCP) WENT TO RE-CAP THE SCALPEL OBTAINED FROM THE ECONOMY SOFT TISSUE BIOPSY TRAY, THE HCP EXPERIENCED A FINGER CUT; THEREFORE, THE HCP APPLIED A BANDAGE, AND THE ISSUE WAS CONSIDERED RESOLVED AS NO FURTHER CARE WAS NECESSARY NOR WAS IT REQUESTED BY THE HCP. THE PATIENT REPORTEDLY DID NOT HAVE ANY INFECTIOUS DISEASES AND WAS TREATED WITHOUT ANY DIFFICULTIES AND NO OTHER WORKFLOW INTERRUPTIONS HAPPENED AFTER THE INCIDENT.
Patient problems: Needle Stick/Puncture
MAUDE report 22691623 ↗
MalfunctionNov 9, 2023Contamination; Contamination
IT WAS REPORTED BY CUSTOMER THAT HAIR FOUND INSIDE OF PACKAGING. VERBATIM. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. HAIR FOUND INSIDE OF PACKAGING. INJURIES OR ADVERSE EVENT: NO. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. PER FOLLOW-UP- LOOKS LIKE THE PACKAGE IS NOT OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18103621 ↗

Device details

UDI-DI	`10885403108563`
Brand	N/A
Model	4380
Company	Carefusion 2200, Inc
Product code	FSH · Tray, surgical, needle
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 1, 2023

Device type (GMDN): Soft-tissue biopsy procedure kit, medicated

A collection of sterile devices, which includes a pharmaceutical(s), designed to perform a non-specific soft tissue biopsy (e.g., skin biopsy, breast biopsy); it is not dedicated to biopsy of a specific internal organ. It includes the biopsy needle used for this procedure. This is a single-use device.

Other Tray, surgical, needle devices

N/A 4382A
Carefusion 2200, Inc · Tray, surgical, needle
2 reports
JAMSHIDI SN1015X
Carefusion 2200, Inc · Tray, surgical, needle
1 report
JAMSHIDI SN7016X
Carefusion 2200, Inc · Tray, surgical, needle
1 report
N/A 4382SP
Carefusion 2200, Inc · Tray, surgical, needle
1 report

All Tray, surgical, needle devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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