E-Cath acc. Tsui 211185-40ERecalls & reported problems
Pajunk GmbH Medizintechnologie · E-Cath acc. Tsui SonoPlex Stim cannula 21G x 94mm indwelling catheter 18G x 75mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14048223025298), received between Aug 23, 2018 and Aug 23, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
- Material Split, Cut or Torn1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2018Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn
IRN# (B)(4). E-CATH WAS PULLED LAST NIGHT FROM A COGNITIVELY IMPAIRED PATIENT. THE CATHETER WAS USED ON A SUPRACLAVICULAR BLOCK THAT WAS INDWELLING FOR 6 DAYS. IT WAS REPORTED TO DR. (B)(6) THAT THE CATHETER WAS AN "EASY OUT" UPON REMOVAL. UPON REMOVAL, IT WAS OBSERVED THAT THE TIP MAY BE MISSING AND A PICTURE WAS TAKEN AND SENT TO DR. (B)(6). (PICTURE WILL BE FORWARDED ON AS WELL.). CATHETER WAS THROWN AWAY AND IS NOT AVAILABLE FOR INSPECTION. IN LOOKING AT THE PICTURE IT APPEARS THAT NOT ONLY IS THE TIP MISSING BUT THE CATHETER APPEARS TO HAVE BEEN STRETCHED AS WELL. AT THE TIME OF THIS REPORTING THE PATIENT IS SAID TO BE ASYMPTOMATIC. DR. (B)(6) HAS REQUESTED ADDITIONAL DETAILS ABOUT THE CATHETER MATERIAL (WHETHER OR NOT INERT) AND RECOMMENDATIONS ON NEXT STEPS AND WHETHER REMOVAL OF TIP NEED BE ATTEMPTED.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 7808036 ↗
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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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