SURFLO SV*25BLKRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34987350726224), received between Nov 11, 2020 and Nov 11, 2020 — classified as 2 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE NEEDLE DETACHED FROM THE BUTTERFLY SURFLO WINGED INFUSION SET, AND STAYED IN THE PATIENT'S ARM POST INFUSION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 16OCT2020. THE PATIENT WAS RECEIVING END OF LIFE TREATMENT IN HOSPICE CARE. THE SV DEVICE WAS PLACED ON (B)(6) 2020 FOR SUB-Q MEDICATION DELIVERY AT THE LEFT UPPER SCAPULA. THE PATIENT WAS RESTLESS; HOWEVER, THE NIGHT NURSE DID NOT NOTE ANYTHING UNUSUAL AT BANDAGE SITE. THE NEEDLE WAS DISCOVERED TO BE MISSING ON (B)(6) 2020, WHEN THE SUB-Q SITE WAS BEING DISCONTINUED. X-RAY CONFIRMED THE NEEDLE TO BE 3.5CM FROM THE SITE. THEY ARE NOT REMOVING THE NEEDLE SINCE PATIENT IS AT END OF LIFE, AND REMOVAL WOULD CAUSE MORE HARM THAN LEAVING IT WHERE IT IS. THEY CONFIRMED THE NEEDLE (STEEL) WAS NOT BROKEN, HOWEVER, HAD SLIPPED CLEANLY OUT OF THE BUTTERFLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10823868 ↗
• InjuryNov 11, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE NEEDLE DETACHED FROM THE BUTTERFLY SURFLO WINGED INFUSION SET ,AND STAYED IN THE PATIENT'S ARM POST INFUSION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 16OCT2020. THE PATIENT WAS RECEIVING END OF LIFE TREATMENT IN HOSPICE CARE. THE SV DEVICE WAS PLACED ON (B)(6) 2020 FOR SUB-Q MEDICATION DELIVERY AT THE LEFT UPPER SCAPULA. THE PATIENT WAS RESTLESS; HOWEVER, THE NIGHT NURSE DID NOT NOTE ANYTHING UNUSUAL AT BANDAGE SITE. THE NEEDLE WAS DISCOVERED TO BE MISSING ON (B)(6) 2020, WHEN THE SUB-Q SITE WAS BEING DISCONTINUED. X-RAY CONFIRMED THE NEEDLE TO BE 3.5CM FROM THE SITE. THEY ARE NOT REMOVING THE NEEDLE SINCE PATIENT IS AT END OF LIFE, AND REMOVAL WOULD CAUSE MORE HARM THAN LEAVING IT WHERE IT IS. THEY CONFIRMED THE NEEDLE (STEEL) WAS NOT BROKEN, HOWEVER, HAD SLIPPED CLEANLY OUT OF THE BUTTERFLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10823861 ↗