SURSHIELD SV*S23BLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 36927675503962), received between Nov 20, 2019 and Nov 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE NURSE RECEIVED A NEEDLE STICK INJURY BECAUSE THE SAFETY COVER DID NOT FULLY ENGAGE OVER THE SHARP END OF THE NEEDLE. THE NURSE REPORTS THAT SHE OFTEN FINDS THE SAFETY COVER ON THE PRODUCT "FINICKY" AND UNRELIABLE. THIS POSES A SAFETY RISK FOR OUR STAFF. RECEIVED A VOLUNTARY HEALTH (B)(6) REPORT, (B)(6) REPORT NUMBER (B)(4). ADDITIONAL INFORMATION WAS RECEIVED 25OCTOBER2019: THE NURSE WAS TESTED BASED ON THEIR PROTOCOL. THEY WILL SEND AN UPDATE IF THERE IS ANY SERIOUS NEGATIVE IMPACT. ADDITIONAL INFORMATION WAS RECEIVED 29OCTOBER2019: THE CUSTOMER DESCRIBED THAT "THE SAFETY COVER DID NOT FULLY ENGAGE OVER THE SHARP END OF THE NEEDLE." WHICH OCCURRED AFTER THE SAFETY DEVICE WAS ACTIVATED, THE NEEDLE DETACHED FROM SAFETY COVER, WHICH CAUSED THE FINGER TO BE MISTAKENLY STUCK BY THE NEEDLE. THE INCIDENT OCCURRED AFTER THE BLOOD DRAW, SO POST-TREATMENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9347623 ↗