BEUDAMED

Tool · Post-Market Surveillance

PSUR Report

The vigilance database section of your PSUR, generated in seconds: FDA MAUDE adverse event trends, recalls, and enforcement classifications for your device and similar devices — with the documented, reproducible methodology auditors ask for.

Reporting period 2024-07 – 2026-06 · FDA data refreshed ~monthly

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Product Code: ONB FDA class 2

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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Adverse events in period

1,565

+53% vs. prior period (1,022)

Deaths reported

0

Recalls in period

41

Class I enforcement

0

Adverse events per month

2024-07 – 2026-06

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Events by type

Period vs. prior period

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Event type

Period

Prior

Injury

25

12

Malfunction

1,531

1,005

Other

9

5

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Most reported coded problems

Top 15

Product problems

Count

Fluid/Blood Leak

428

Leak/Splash

339

Disconnection

218

Contamination

93

No Flow

70

Particulates

69

Break

65

Material Separation

55

Defective Component

51

Device Contamination with Chemical or Other Material

50

Connection Problem

43

Infusion or Flow Problem

25

Air/Gas in Device

21

Separation Problem

20

Inflation Problem

18

Patient problems

Count

No Clinical Signs, Symptoms or Conditions

1,360

Chemical Exposure

133

Insufficient Information

85

Hemorrhage/Blood Loss/Bleeding

11

Extravasation

1

Cerebrospinal Fluid Leakage

1

Cancer

1

Burning Sensation

1

Altered State of Consciousness

1

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Recalls in period

41 total

FDA enforcement classification: Class II: 41

Date

Recalling firm

Status

Reason

2026-03-24

ICU Medical, Inc.

Open, Classified

Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-09-08

ICU Medical, Inc.

Open, Classified

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

2025-06-16

/fda_recalls/Z-2453-2025

Open, Classified

Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

2024-11-06

ICU Medical, Inc.

Open, Classified

Due to finished goods incorrectly packaged and labeled.

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Adverse events by year

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Methodology & data provenance

For your PSUR appendix

Search protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code ONB, reporting period 2024-07 to 2026-06 (prior comparison period 2022-07 to 2024-06).

Data coverage: adverse event data for these product codes extends through 2026-05. Source openFDA export dated 2026-06-30. Recall records with missing or implausible initiation dates (0 for these codes) are excluded from period counts.

Generated: 2026-07-05 21:22 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.

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PSUR database searches, explained

Under the EU MDR, manufacturers must produce a Periodic Safety Update Report (PSUR) (Class IIa and above; a PMS report for Class I) on a defined schedule. A required part of that report is a survey of publicly available vigilance data — most importantly the FDA's MAUDE adverse event database and FDA recall records — covering both your own device and similar devices on the market (the "state of the art").

Doing this by hand means repeated MAUDE queries, manual export, deduplication, and trending — hours of work per report, repeated every reporting period. This tool runs the same search protocol in seconds and documents it: which datasets were queried, with which filters, when, and with what coverage — so the search is reproducible, which is exactly what a Notified Body auditor wants to see.

Event counts are grouped by the FDA's reported event type (death, injury, malfunction). Name-based device matching is clearly labeled as indicative: only you can confirm whether a specific MAUDE report concerns your device. Recall records with implausible dates are excluded and the exclusion is disclosed. All data is from the official openFDA datasets and refreshed approximately monthly.