Alaris, VersaSafe 21001M-07Recalls & reported problems
BD Switzerland Sàrl · Extension Set, Smallbore Tubing T-Connector with Split Septum Port 13 cm (5 in) · Class 2
All models of Alaris, VersaSafe (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885403222832), received between Aug 28, 2018 and Aug 29, 2018 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break9
Patient problems
- No Known Impact Or Consequence To Patient9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2018Break; Break
THE CUSTOMER REPORTED THE T-CONNECTOR EXTENSION SET CRACKED AND/OR DISCONNECTED FROM THE CENTRAL VENUS LINE (CVL) DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7830820 ↗MalfunctionAug 29, 2018Break; Break
THE CUSTOMER REPORTED THE T-CONNECTOR EXTENSION SET CRACKED AND/OR DISCONNECTED FROM THE CENTRAL VENUS LINE (CVL) DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7830815 ↗MalfunctionAug 29, 2018Break; Break
THE CUSTOMER REPORTED THE T-CONNECTOR EXTENSION SET CRACKED AND/OR DISCONNECTED FROM THE CENTRAL VENUS LINE (CVL) DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7830766 ↗MalfunctionAug 29, 2018Break; Break
THE CUSTOMER REPORTED THE T-CONNECTOR EXTENSION SET CRACKED AND/OR DISCONNECTED FROM THE CENTRAL VENUS LINE (CVL) DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7830763 ↗MalfunctionAug 29, 2018Break; Break
THE CUSTOMER REPORTED THE T-CONNECTOR EXTENSION SET CRACKED AND/OR DISCONNECTED FROM THE CENTRAL VENUS LINE (CVL) DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7830716 ↗MalfunctionAug 29, 2018Break; Break
THE CUSTOMER REPORTED THE T-CONNECTOR EXTENSION SET CRACKED AND/OR DISCONNECTED FROM THE CENTRAL VENUS LINE (CVL) DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7830691 ↗MalfunctionAug 28, 2018Break; Break
THE CUSTOMER REPORTED THE T-CONNECTOR EXTENSION SET CRACKED AND/OR DISCONNECTED FROM THE CENTRAL VENUS LINE (CVL) DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7824744 ↗MalfunctionAug 28, 2018Break; Break
THE CUSTOMER REPORTED THE T-CONNECTOR EXTENSION SET CRACKED AND/OR DISCONNECTED FROM THE CENTRAL VENUS LINE (CVL) DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7824739 ↗MalfunctionAug 28, 2018Break; Break
THE CUSTOMER REPORTED THE T-CONNECTOR EXTENSION SET CRACKED AND/OR DISCONNECTED FROM THE CENTRAL VENUS LINE (CVL) DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7824678 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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