Alaris C20022Recalls & reported problems
BD Switzerland Sàrl · Extension Set, 51 cm (20 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403235498), received between Aug 28, 2020 and Sep 28, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (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.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Separation1
- Difficult to Remove1
- Leak/Splash1
- Problem with Sterilization1
Patient problems
- Missed Dose1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Problem with Sterilization
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924401 ↗InjurySep 2, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 20 INCH EXT SET BROKE OFF IN THE LUMEN OF THE PICC LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: C20022, BATCH NO: 20056787. IT WAS REPORTED THAT THE TIP OF THE TUBING BROKE OFF IN THE LUMEN DUE TO DIFFICULTY REMOVING EXTENSION SETS. CUSTOMER RESPONSE (B)(6) 2020: "THE MALE PIECE FROM THE EXTENSION TUBING BROKE OFF IN THE PICC LINE. PLEASE SEE MY RESPONSES TO YOUR QUESTIONS BELOW. ADDITIONALLY PLEASE ADVISE ON THE ADDITIONAL INQUIRY REGARDING THE ADVERSE EVENT: COULD YOU PROVIDE CONFIRMATION THAT THE LINE WAS A CENTRAL LINE AND NOT A PERIPHERAL LINE? ADDITIONALLY, DID IT NEED TO BE REPLACED? THIS WAS A PICC LINE WHICH HAD TO BE REMOVED; WE PLACED A PERIPHERAL IV AS THE PATIENT¿S ANTIBIOTIC THERAPY WAS NOT COMPLETED. PT HAD 3 MORE DAYS OF ANTIBIOTIC THERAPY. BECAUSE THE MEDICATION REGIMEN WAS COMPLETED 3 DAYS EARLY, WERE ANY DOSES OF MEDICATION MISSED? THIS IS NOT ACCURATE. THE PATIENT¿S MEDICATION REGIMEN WAS NOT COMPLETE. PT HAD 3 MORE DAYS OF THERAPY." CUSTOMER RESPONSE (B)(6) 2020: ARE YOU ABLE TO PROVIDE A PART NO AND BATCH NO FOR THE REPORTED EXTENSION TUBING? REF (B)(4), LOT# (10)20056787. WAS THERE ANY ADVERSE EVENT(S
Patient problems: Missed Dose
MAUDE report 10486232 ↗InjuryAug 28, 2020Difficult to Remove; Difficult or Delayed Separation; Difficult to Remove; Difficult or Delayed Separation
IT WAS REPORTED THAT THE 20 INCH EXT SET EXPERIENCED DIFFICULTY DISCONNECTING THE DEVICE WHICH CAUSED THE PICC TO BE REMOVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBING WAS PLACED DIRECTLY INTO A LUMEN OF A PICC AND NOT INTO THE NEEDLELESS CONNECTOR. CUSTOMER RESPONSE 25-AUG-2020: ¿ ARE YOU ABLE TO PROVIDE A PART NO AND BATCH NO FOR THE REPORTED EXTENSION TUBING? REF# (B)(4) LOT# (10)20056787; ¿ WAS THERE ANY ADVERSE EVENT(S) AS A RESULT OF THE REPORTED DEFECT? YES PT.¿S PICC LINE HAD TO BE REMOVED PREMATURELY.
Patient problems: No Information
MAUDE report 10468519 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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