Alaris 10031776Recalls & reported problems
BD Switzerland Sàrl · Extension Set, Smallbore Tubing 594 cm (234 in) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403234095), received between Sep 30, 2020 and Sep 30, 2020 — classified as 1 death.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathSep 30, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AS LVP 20D 3SS CV WAS USED ON A COVID-19 POSITIVE PATIENT WHO DIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10031776 ; BATCH NO: 20065112. IT WAS REPORTED THAT A PRODUCT FAILURE WITH ITEM 10031776 MAY HAVE RESULTED IN A PATIENT DEATH. BD REP RESPONSE 14-SEP-2020: "I SPOKE WITH (B)(6) AT (B)(6) THIS PAST THURSDAY AND THEY DO HAVE ONE OF THE TUBING SETS THAT FAILED. SINCE THIS TUBING WAS CONNECTED TO A PATIENT THAT WAS COVID-19 POSITIVE, HOW DO WE GO ABOUT SENDING THAT INTO BD?" CUSTOMER RESPONSE 11-SEP-2020: "SENDING THIS REQUEST TO THE APPROPRIATE STAFF FOR INFORMATION BASED ON REQUEST BELOW." "I RECEIVED A PHONE CALL FROM XXXXXXXXXXXX AT (B)(6) HEALTH STATING THAT THERE WAS A PRODUCT FAILURE WITH ITEM 10031776 WHICH MAY HAVE RESULTED IN A PATIENT DEATH. I SPOKE WITH HER AT 10:00 AM REGARDING THIS EVENT. XXXXXXX IS IN SUPPLY CHAIN AT (B)(6) AND CAN PUT US IN TOUCH WITH THE END USERS WHO EXPERIENCED THE EVENT AND PROVIDE MORE DETAIL. "
Patient problems: Death
MAUDE report 10605984 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.