Midline Catheter Kit S4153108BPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741153990), received between Apr 8, 2022 and Apr 8, 2022 — classified as 1 injury.

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

1 FDA recall record name this device's identifier, 1 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. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2667-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2022Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "WHEN THE PICC LINE WAS BEING REMOVED THE GUIDE WIRE BECAME STUCK, AND WHEN IT WAS REMOVED THE WIRE WAS FRAYED AND THE J TIP HAD BEEN LOST. THIS FRAYING OCCURRED DISTALLY ALONG THE GUIDEWIRE VERY HIGH UP THE HUMERUS AND THE CARE PROVIDER DID NOT FEEL THAT EXCESSIVE FORCE WAS USED IN ADVANCING OR RETRACTING THE GUIDEWIRE. RADIOLOGY CONFIRMED THE RETAINED GUIDEWIRE FRAGMENT AND DETERMINED THAT DUE TO ITS SMALL SIZE, IT WAS NOT CLINICALLY SIGNIFICANT AND RISKS INHERENT TO ATTEMPTED REMOVAL WOULD OUTWEIGH ANY BENEFIT." ADDITIONAL INFORMATION RECEIVED 03/29/2022: A DETAILED DESCRIPTION OF THE PLACEMENT: PLACED ON OR AFTER (B)(6) 2022 IN THE RIGHT HUMERUS AFTER UNSUCCESSFUL MIDLINE CATHETER PLACEMENT. HOW WAS THE BREAK AND/OR RETAINED SEGMENT DISCOVERED? ARE RADIOGRAPHIC IMAGES AVAILABLE? X-RAY. NO IMAGES AVAILABLE. WHAT TYPE OF IMAGING WAS USED TO VERIFY BROKEN PIECE IN PATIENT? ARE PICTURES AVAILABLE? X-RAY. NO IMAGES AVAILABLE. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? N/A; AS THE BROKEN PIECE WAS THE GUIDEWIRE. WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. NO PATIENT HARM. ANY LONG-TERM PAT

  Patient problems: Foreign Body In Patient

  MAUDE report 14054019 ↗