SPROTTE® 511151-29A (UDI 04048223066898)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048223066898), received between Jun 21, 2021 and Jun 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

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.

Most reported problems

Recent adverse event reports

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

• MalfunctionJun 21, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IRN# (B)(4). TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: "HUB OF INTORDUCER CAME OFF DURING REMOVAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030753 ↗
• MalfunctionJun 21, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IRN# 160-21_729 TENTATIVE SUMMARIZING TRANSLATION FROM INITIAL REPORTER´S NARRATIVE: "THE INCIDENT HAVE BEEN REPORTED BY AN ANESTHETIST FROM HOSPITAL (B)(6). ACCORDING TO THE REPORTER, AFTER PERFORMING A SPINAL PUNCTURE, THE NEEDLE SEPARATED FROM THE CONE. THIS ISSUE WAS NOTIFIED TO THE HOSPITAL PURCHASING DEPARTMENT." CER: THE OUTER CANNULA OF THE 25GX90CM PAJUNK SPROTTE NEEDLE WAS DETACHED FROM THE CONNECTOR ITSELF. THERE WAS NO INCIDENCE IN THE PATIENT. A SAMPLE UNIT IS AVAILABLE TO SEND TO THE SUPPLIER. THE CLIENT REPORTS ON (B)(6), 2021 THAT WHEN REMOVING THE NEEDLE AFTER PERFORMING A SPINAL PUNCTURE, HE DISASSEMBLED FROM THE CONE. THE PROCEDURE COULD BE CARRIED OUT WITHOUT PROBLEM AND IT IS RECONFIRMED THAT THE INCIDENT HAD NO IMPACT ON THE PATIENT. EMAILS WITH THE CLIENT ARE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030752 ↗