Medline Industries, Inc. PAIN1423ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489201826), received between Jun 20, 2024 and Jun 27, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 16, 2024Class IIOpen, Classified

   The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

   Z-0512-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 18, 2023Class IIOpen, Classified

   Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

   Z-2166-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY THE "CONNECTOR DOES NOT SECURELY STAY ATTACHED TO THE CATHETER DUE TO IMPROPER FIT".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19624076 ↗
• InjuryJun 20, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER, "WE HAVE HAD 3 CONNECTORS FOR THE MEDLINE PERIPHERAL CONTINUOUS NERVE BLOCK KIT CONNECTORS FAIL IN THE PAST WEEK. THE CONNECTOR LEAKS AND FALLS OFF THE CATHETER".

  Patient problems: Insufficient Information

  MAUDE report 19578354 ↗
• InjuryJun 20, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER, "WE HAVE HAD 3 CONNECTORS FOR THE MEDLINE PERIPHERAL CONTINUOUS NERVE BLOCK KIT CONNECTORS FAIL IN THE PAST WEEK. THE CONNECTOR LEAKS AND FALLS OFF THE CATHETER".

  Patient problems: Insufficient Information

  MAUDE report 19577565 ↗
• InjuryJun 20, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER, "WE HAVE HAD 3 CONNECTORS FOR THE MEDLINE PERIPHERAL CONTINUOUS NERVE BLOCK KIT CONNECTORS FAIL IN THE PAST WEEK. THE CONNECTOR LEAKS AND FALLS OFF THE CATHETER".

  Patient problems: Insufficient Information

  MAUDE report 19576175 ↗