Extension Set 470065Recalls & reported problems
B. Braun Medical Inc. · Small bore extension set with non-removable slide clamp and SPIN-LOCK® connector with priming volume: 0.5 mL. Length 17 in. (43 cm) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964298097), received between May 6, 2021 and May 6, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE PATIENT: "THE FAILURE I EXPERIENCED A FEW DAYS AGO WAS BETWEEN THE LIGHT GREEN FEMALE LUER ON THE 17" EXTENSION SET AND THE BACKCHECK FLOW VALVE. THEY DISCONNECTED ENTIRELY WHILE INFUSING (AN EXTREMELY SLOW RATE OF 12.5ML/HR) WHICH RESULTED IN BLOOD COMING OUT THE EXTENSION SET." NO INJURY REPORTED. POSSIBLE LOT NUMBERS PROVIDED: LOT NUMBER 0061757951: EXPIRY DATE 12/31/2025; PRODUCTION DATE 01/07/2021. LOT NUMBER 0061735484: EXPIRY DATE 04/30/2025; PRODUCTION DATE 05/22/2020. LOT NUMBER 0061749271: EXPIRY DATE 08/31/2025; PRODUCTION DATE 09/11/2020.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11786967 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.