N/A 385121Recalls & reported problems
Becton, Dickinson And Company · J Connector Loop · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382903851219), received between Oct 3, 2018 and Nov 17, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash3
- Device Contamination with Chemical or Other Material1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE J CONNECTOR LOOP EXPERIENCED AN EXTENSION SET THAT WAS LOOSE/SEPARATED/DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: J LOOP POPS OUT OF CANNULA - ISN'T SECURE. NEW POLICY MANDATING USE OF J LOOPS. WHEN FILMING NEW PROCEDURE NOTED THAT JLOOPS POP OUT OF CANNULA AS THEY ARE LUER SLIP. THIS HAS BEEN ONGOING FOR A LONG TIME AND REASON THEY ARE NOT BEING USED FREQUENTLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10857180 ↗MalfunctionAug 10, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT J CONNECTOR LOOP SPLIT OPEN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAD A J-LOOP CONNECTOR SPLIT OPEN WHILE DELIVERING CONTRAST IN CT. THE RATE OF DELIVERY WAS 5ML PER SECOND.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10388926 ↗MalfunctionOct 3, 2018Leak/Splash
IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE CONNECTION BETWEEN THE BD¿ J CONNECTOR LOOP WITH FLEXIBLE EXTENSION TUBING AND THE REFLUX VALVE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7930669 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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