BD Perisafe™ 409443Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382904094430), received between Dec 27, 2017 and Dec 30, 2020 — classified as 2 injuries, 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2020Break; Break

  IT WAS REPORTED THAT THE NEEDLE SP S/SU 27GA 4-11/16IN WHITACRE BROKE OFF IN THE PATIENT, RESULTING IN UNEXPECTED MEDICAL INTERVENTION AND A DELAY IN TREATMENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "(B)(6) - FOREIGN BODY IN PATIENT, UNEXPECTED MEDICAL INTERVENTION, DELAY TO TREATMENT/(B)(4), BREAK"

  Patient problems: Foreign Body In Patient

  MAUDE report 11095611 ↗
• InjuryDec 23, 2020Break; Break

  IT WAS REPORTED THAT A NEEDLE SP S/SU 27GA 4-11/16IN WHITACRE BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER INFORMS THAT A LONGER SPINAL NEEDLE WAS NEEDED TO TAKE INTO THE INTRODUCING OF SPINAL NEEDLE THROUGH INTRODUCER DUE TO THICK SUBCUTIS OF THE PATIENT. A SHORTER INTRODUCER REF 405075 (LOT 2003017) WAS USED SINCE NO LONGER INTRODUCER WAS AVAILABLE. ONCE THE DOCTOR WAS PULLING THE SPINAL NEEDLE OUT THROUGH THE INTRODUCER 405075, THE NEEDLE BROKE INTO TWO PIECES, LEAVING THE DISTAL END OF THE NEEDLE (ABOUT 5 CMS OF THE NEEDLE) IN THE SOFT TISSUE OF THE PATIENTS SPINE, ABOUT 10 CMS DEEP IN THE SPINE. DUE TO THIS INCIDENT THE KNEE PROCEDURE HAD TO BE DONE UNDER GENERAL ANASTHESIA INSTEAD OF THE PRE-PLANNED SPINAL ANASTHESIA. AT THE END OF THE KNEE PROCEDURE, A SPINAL SURGEON HAD TO REMOVE THE 5 CM PIECE OF SPINAL NEEDLE FROM THE PATIENTS BACK WHILE THE PATIENT WAS STILL UNDER ANASTHESIA. AUTHORITIES HAVE BEEN NOTIFIED BY THE HOSPITAL AND ALSO THE PATIENT HAS MADE AN OFFICIAL MALPRACTISE COMPLAINT. THE INTRODUCER REF (B)(6) THAT WAS USED WITH THE SPINAL NEEDLE REF (B)(6) WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION. THE SAMPL

  Patient problems: Foreign Body In Patient

  MAUDE report 11061781 ↗
• MalfunctionDec 27, 2017Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BEFORE USE OF THE NEEDLE SP S/SU WHITACRE, THE PRODUCT WAS RECEIVED DAMAGED DUE TO A PERFORATION IN THE SEAL OF THE PACKAGING. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148623 ↗