BD SmartSite 30843ERecalls & reported problems
BD Switzerland Sàrl · PCA Extension Set Smallbore Tubing Segment Check Valve Needle-Free Valve 30 cm (12 in) · 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 10885403235214), received between Oct 30, 2025 and Oct 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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.
Reports received per month
Most reported problems
Device problems
- Crack1
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.
MalfunctionOct 30, 2025Crack; Crack
IT WAS REPORTED THAT THE BD ALARIS PCA SS CV WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A NURSE MANAGER REPORT THAT WHEN CONNECTING/PRIMING A PCA EXT SET (REF: 30843E) TO THE PRIMARY TUBING THEY NOTICED A CRACK IN THE EXTENSION SET TUBING AT THE CONNECTION SITE OF THE EXTENSION SET AND THE IV TUBING. I¿M UNCERTAIN IF THIS WAS FROM TIGHTENING THE TUBING TOO TIGHT OR IF IT WAS LIKE THAT WHEN THEY PULLED IT OUT OF THE PACKAGING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2025 CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? (10)25085756
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23421207 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.