BD Perisafe™ 405138Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382904051389), received between Feb 25, 2020 and May 27, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Material Separation; Material Separation

  MATERIAL # 405138, BATCH # 4304716. IT WAS REPORTED BY CUSTOMER THAT WHEN ADVANCING SPINAL NEEDLE, IT SEPARATED AND WAS LODGED IN THE PTS SPINAL. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. ISSUE: WHEN ADVANCING SPINAL NEEDLE, IT SEPARATED AND WAS LODGED IN THE PTS SPINAL COLOMN. PT DID REQUIRE DIGANOSITCS AND SURGER TO REMOVE THE OTHER END. PT HARM: YES.

  Patient problems: Foreign Body In Patient

  MAUDE report 22086972 ↗
• MalfunctionFeb 20, 2025Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21421491 ↗
• InjuryJan 3, 2023Break; Break

  IT WAS REPORTED THAT THE BD WHITACRE¿ SPINAL NEEDLE WAS FOUND "SHEARED OFF" WHEN REMOVING IT FROM THE EPIDURAL LIGAMENT. AS A RESULT, THE PATIENT'S CARDIAC SURGERY WAS POSTPONED, AND GENERAL ANESTHESIA WAS NEEDED TO EXTRACT THE BROKEN NEEDLE PIECE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ATTEMPTED SPINAL PROCEDURE WITH 27G WHITACRE. THE NEEDLE WAS PASSED THROUGH THE 20G INTRODUCER AND ADVANCED INTO THE EPIDURAL LIGAMENT. NO CSF ENDPOINT WAS OBTAINED. THE INTRODUCER WAS REPLACED AND SPINAL NEEDLE ADVANCED TO THE HUB AND THERE STILL WAS NO CSF. THE NEEDLE WAS THEN WITHDRAWN. AFTER WITHDRAWING THE NEEDLE WAS FOUND TO BE SHEARED OFF. THE PATIENT'S CARDIAC SURGERY WAS POSTPONED. THE PATIENT REQUIRED GENERAL ANESTHESIA FOR EXTRACTION OF THE NEEDLE. THE PATIENT LATER HAD CARDIAC SURGERY. THERE WERE NO LONG TERM ADVERSE PATIENT IMPACT. BECTON DICKINSON CANADA INC YES / OUI CANADIAN HOSPITAL SPECIALTIES LTD (B)(6) 2022, PENDING ASSIGNMENT NO / NON A0401 - BREAK / BRIS; E2403 - NO CLINICAL SIGNS SYMPTOMS OR CONDITIONS / AUCUN SIGNE, SYMPTÔME OU CONDITION CLINIQUES; F19 - SURGICAL INTERVENTION / INTERVENTION CHIRURGICALE; F1909 - SURGICAL PROCEDURE DELAYED / PROCÉDURE

  Patient problems: Foreign Body In Patient

  MAUDE report 16091562 ↗
• InjuryDec 20, 2022Break; Break

  IT WAS REPORTED THAT THE BD WHITACRE HIGH FLOW PENCIL POINT SPINAL NEEDLES, STERILE, SINGLE USE WAS SHEARED OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ATTEMPTED SPINAL PROCEDURE WITH 27G WHITACRE. THE NEEDLE WAS PASSED THROUGH THE 20G INTRODUCER AND ADVANCED INTO THE EPIDURAL LIGAMENT. NO CSF ENDPOINT WAS OBTAINED. THE INTRODUCER WAS REPLACED, AND SPINAL NEEDLE ADVANCED TO THE HUB AND THERE STILL WAS NO CSF. THE NEEDLE WAS THEN WITHDRAWN. AFTER WITHDRAWING THE NEEDLE WAS FOUND TO BE SHEARED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017720 ↗
• InjuryOct 29, 2022Break; Break

  IT WAS REPORTED WHILE USING BD WHITACRE HIGH FLOW PENCIL POINT SPINAL NEEDLES, STERILE, SINGLE USE THE NEEDLE BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BROKE OFF IN PATIENT, CT SCAN AND INCISION REQUIRED FOR REMOVAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696053 ↗
• MalfunctionJul 7, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE BD 405138 WHITACRE HIGH-FLOW PENCIL POINT SPINAL NEEDLE EXPERIENCED PACKAGING DAMAGE WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WRAPPING PAPER OF PRODUCT IS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946558 ↗
• InjuryOct 27, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT NEEDLE SP S/SU 25GA TW 3-1/2IN WHITACRE WAS USED WHILE DAMAGED. THIS LED TO SURGICAL INTERVENTION AND RADIOLOGICAL IMAGING TO ENSURE THAT FOREIGN MATTER DID NOT REMAIN IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT THE TIME OF DISCARDING THE SHARP MATERIAL, IT WAS IDENTIFIED THAT # 25 WHITACRE NEEDLE WAS FRACTURED, WHICH WAS USED TO ATTEMPT TO PLACE SPINAL ANESTHESIA, IT IS NECESSARY TO RULE OUT THE PRESENCE OF A FOREIGN BODY (NEEDLE) IN THE LUMBAR WORKING CHANNEL. I SHARE THE ACTIONS GENERATED WITH THE EVENT: WHEN THE NEEDLE FRACTURE WAS EVIDENCED, IT WAS NOT POSSIBLE TO FIND A DISTAL FRAGMENT; ON SUSPICION OF REMAINING IN THE WORKING CHANNEL, RADIOLOGICAL CONTROL WAS CARRIED OUT WITH AN IMAGE INTENSIFIER TO RULE OUT THE NEEDLE IN THAT CHANNEL AND A NEUROSURGICAL CONSULTATION WAS REQUESTED. IMAGING STUDY RULES OUT THE PRESENCE OF A FOREIGN BODY IN THE LUMBAR PERIVERTEBRAL REGION. WHEN FINISHING THE CLEANING IN THE OPERATING ROOM, THE CLEANING STAFF FOUND A NEEDLE FRAGMENT ON THE FLOOR OF THE OPERATING ROOM, DEFINITIVELY RULING OUT THE PRESENCE OF A FOREIGN BODY ON THE PATIENT'S SKIN".

  Patient problems: Foreign Body In Patient

  MAUDE report 10744357 ↗
• InjuryFeb 25, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE PULLED OUT DURING USE AND REMAINED IN INJECTION SITE RESULTING IN SURGERY TO REMOVE WITH A BD NEEDLE SP S/SU 25GA TW 3-1/2IN WHITACRE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE NEEDLE SHEARED OFF IN A PATIENT'S BACK RESULTING IN THE PATIENT HAVING SURGERY TO GET IT REMOVED.

  Patient problems: Tissue Damage

  MAUDE report 9751329 ↗