SmartSite 10012143Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403233661), received between Mar 14, 2019 and Sep 25, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionSep 25, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT BD SMART SITE EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: DESCRIBE THE EVENT OR PROBLEM: ADULT FEMALE GESTITIONAL AGE 40W6D RECEIVING PITOCIN DURING L&D; RN NOTICED BEDDING WAS SOAKING AND NOTED PITOCIN DRAINING FROM HUB ON Y CONNECTOR AS IT WAS CRACKED. PT HAD PROLONGED SECOND STAGE, VAC ASSIST W/3 POP-OFFS AND POTENTIAL C/S BUT BABY DELIVERED VAGINALLY FROM ROA POSITION. MOM & BABY TOLERATED DELIVERY WELL, NO COMPLICATIONS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808048 ↗
• InjuryMar 14, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM THE FDA WHICH STATES, ¿FEMALE AT (B)(6) GESTATION PRESENTED WITH CONTRACTIONS GETTING STRONGER SINCE MIDNIGHT. PATIENT TUBING ON IV SET APPEARED TO HAVE BROKEN RIGHT ABOVE Y CONNECTION. NURSE ABLE TO CLAMP IT OFF AND CALL FOR HELP AND CHANGE OUT THE IV. THE MEDSUN PROVIDED ADDITIONAL INFORMATION UNDER "WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: TUBING BROKE RIGHT ABOVE Y CONNECTION. NURSE WAS IN ROOM AND PT. STATED THAT HER IV CAME UNDONE. NURSE WAS IN ROOM AND PATIENT STATED HER IV HAD COME UNDONE. NURSE WENT TO BEDSIDE AND CLAMPED TUBING TO AVOID BLOOD LOSS AND CALLED FOR HELP. THE ORIGINAL TUBING HAD NOT EVER BEEN CLAMPED AT THIS "BROKEN" SECTION OF TUBING. NO HARM TO PATIENT, NO EST BLOOD LOSS." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420354 ↗