Multi-Sampling Connector 4R5129Recalls & reported problems
Fresenius Kabi AG · Semi-Assembled Multi-Sample Access Device. · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04086000101240), received between Nov 8, 2024 and Nov 8, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Foreign Body In Patient2
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2024Break; Break
IT WAS REPORTED THE LUER ADAPTORS HAVE BROKE IN THE CVC HUBS WHEN THEY ARE ATTEMPTING TO GET PRE LABS. HAVE HAD 3 PATIENT SAFETY EVENTS OF THE ADAPTER BREAKING OF INTO THE CVC HUB AND HAVING TO BE SENT TO ER TO HAVE CVC REPAIR. MULTIPLE LOTS REPORTED (22J11B (MANUFACTURED: 10/11/2022, EXPIRES: 09/30/2027), 22J14B (MANUFACTURED 10/14/2022, EXPIRES: 09/30/2027). NOTE: MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL DETAILS ABOUT THE INCIDENT AND PATIENT STATUS, WITH NO RESPONSE.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 20637837 ↗MalfunctionNov 8, 2024Break; Break
IT WAS REPORTED THE LUER ADAPTORS HAVE BROKE IN THE CVC HUBS WHEN THEY ARE ATTEMPTING TO GET PRE LABS. HAVE HAD 3 PATIENT SAFETY EVENTS OF THE ADAPTER BREAKING OF INTO THE CVC HUB AND HAVING TO BE SENT TO ER TO HAVE CVC REPAIR. MULTIPLE LOTS REPORTED (22J11B (MANUFACTURED: 10/11/2022, EXPIRES: 09/30/2027), 22J14B (MANUFACTURED 10/14/2022, EXPIRES: 09/30/2027)). NOTE: MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL DETAILS ABOUT THE INCIDENT AND PATIENT STATUS, WITH NO RESPONSE.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 20637725 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.