BD Perisafe™ 405079Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382904050795), received between Sep 23, 2019 and Oct 29, 2025 — classified as 5 injuries, 4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Break; Break

  NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 23413340 ↗
• MalfunctionJul 7, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT IS REPORTED CONNECTION ISSUE WITH NEEDLE AND SYRINGE. EVENT DETAILS: THE NEEDLE DOES NOT FIT PROPERLY WITH THE DIFFERENT SYRINGES THAT WERE TESTED, RESULTING IN LEAKAGE DURING THE ADMINISTRATION OF THE MEDICATION IN THIS CASE FOR ANESTHESIA. ADDITIONAL INFORMATION COULD YOU PLEASE CONFIRM IF THE DIFFERENT SYRINGES TESTED ARE FROM BD? YES. COULD YOU PLEASE PROVIDE THE SYRINGE CATALOG AND LOT NUMBER? 4134412. COULD YOU PLEASE CLARIFY THIS MATCHING PROBLEM USING THE SAME OR DIFFERENT PRODUCT CATALOGS? NO. IS THERE ANY IMPACT FOR THE PATIENT? YES. PROVIDE DETAILS OF THE IMPACT/HARM TO THE PATIENT? DETECTED PRIOR TO ADMINISTRATION WAS THERE EXPOSURE TO BLOOD OR CHEMOTHERAPY ON MUCOUS MEMBRANES OR SKIN (DETAIL)? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410750 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE BROKEN. VERBATIM: THE BROKEN NEEDLE I BROUGHT TO YOU WAS A BD NEEDLE, NOT A XXX NEEDLE. THE DOCTOR GIVE IT TO ME TOGETHER WITH THE XXX TRAY, AND I THOUGHT IT WAS A XXX NEEDLE. ADDITIONAL INFORMATION RECEIVED ON 18JUN2025. 1. CAN YOU PLEASE PROVIDE THE MATERIAL NUMBER/ LOT NUMBER OF THE PRODUCT ASSOCIATED WITH REPORTED ISSUE? DON¿T KNOW THE MATERIAL OR LOT NUMBERS. 2. WHEN WAS THE NEEDLE BROKE? DURING OR BEFORE USE? NEEDLE BROKE DURING USE INSIDE PATIENT. 3. DID THE REPORTED ISSUE HAVE ANY IMPACT ON THE PATIENT OR HCP? PATIENT REQUIRED SURGERY TO REMOVE BROKEN NEEDLE FROM THE SPINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22289238 ↗
• MalfunctionJan 13, 2025Difficult to Insert; Difficult to Insert

  NEEDLE STUCK WHEN TRYING TO REMOVE FROM SHEATH (SEE PICTURE). NEEDLE RESISTANCE WHEN TRYING TO INSERT INTO INTRODUCER. SCRATCHING FEELING WHEN REMOVING FROM INTRODUCER WHICH BLUNTS THE NEEDLE. OLD PACKAGING OF 405079 (BATCH: 1120615) DOES NOT HAVE ABOVE PROBLEM, PUT TOGETHER IN BOX FOR REFERENCE AND COMPARISON. 405260 INTRODUCER NEEDLE PUT TOGETHER FOR TESTING SCRATCHING SOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138370 ↗
• MalfunctionOct 10, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD® QUINCKE SPINAL NEEDLE 27G THE NEEDLE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PURCHASE DEPT RECEIVED SPINAL 27G IN BROKEN CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908699 ↗
• InjuryAug 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE BROKE OFF OF THE BD¿ SPINAL NEEDLE WHITACRE STYLE. THE PATIENT REQUIRED SURGICAL REMOVAL OF THE EMBEDDED PORTION OF THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: WHEN USING THE ANESTHESIA NEEDLE, AT THE MOMENT OF PUNCTURING THE PATIENT, IT BROKE INSIDE HER, WHICH HAS MADE THE PHYSICIAN TO OPEN THE PATIENT (SURGICAL INTERVENTION) TO REMOVE THE NEEDLE FRAGMENT. I INSERT THE NEEDLE, AND AT THE MOMENT WHEN IT COLLIDES, WHEN THE NEEDLE RETURNS, THIS ENTIRE PART COMES OUT AND THE OTHER FRAGMENT OF THE NEEDLE REMAINS IN THE PROCESS. AUTOMATICALLY A PIECE COMES TO ME AND THE OTHER STAYS INSIDE. WHEN THAT HAPPENS, I MAKE AN INCISION OF 1 CM MORE OR LESS AND WITH TWEEZERS I MANAGE TO GRAB THE TIP AND REMOVE THE REST OF THE NEEDLE THAT IS INSIDE THE PATIENT. WHAT IS THE CURRENT STATUS OF THE PATIENT? THE PATIENT IS CURRENTLY WELL, SHE HAS NOT PRESENTED IMMEDIATE CONSEQUENCES TO THE EVENT PRESENTED, THERE ARE NO SIGNS OF INFECTION, BRUISING OR NEUROLOGICAL DEFICIT CURRENTLY. WAS THERE ANY LONG-TERM CONSEQUENCE OR HARM DUE TO THE NEEDLE BREAKING, OR DUE TO SURGERY FOR REMOVAL? AS A CONSEQUENCE, IT PRESENTS A

  Patient problems: Needle Stick/Puncture

  MAUDE report 15294891 ↗
• InjuryMar 8, 2022Break; Break

  IT WAS REPORTED WHILE USING BD¿ SPINAL NEEDLE WHITACRE STYLE 27 GAUGE THE NEEDLE BROKE OFF POTENTIALLY IN THE PATIENT. TWO SEPARATE PIECES BROKE. X RAYS AND TOMOGRAPHY WERE PERFORMED AND NOTHING WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE TIME OF TRYING TO BLOCK THE PATIENT, THE ANESTHESIOLOGIST COMMENTS THAT WHEN REMOVING THE NEEDLE IT BROKE, THE ANESTHESIOLOGIST WAS LEFT WONDERING IF IT REALLY BROKE INSIDE THE PATIENT; X-RAYS ARE PERFORMED ON THE PATIENT IN WHICH NO FRAGMENT OF THE NEEDLE CAN BE SEEN. (B)(6) 2022, THE ANESTHESIOLOGIST CONFIRMS THAT A TOMOGRAPHY WAS PERFORMED ON THE PATIENT, NOT FINDING ANY FRAGMENT OF SAID NEEDLE, THE PATIENT IS STABLE AT THE MOMENT THERE ARE TWO PIECES INVOLVED: ONE NEEDLE WAS THE ONE THAT BROKE INSIDE THE PATIENT AND THE OTHER THE ANESTHESIOLOGIST TO CHECK IF IT WOULD SUFFER A BREAK, MANIPULATED IT BEFORE USING IT, CHECKING THAT IT ALSO BROKE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13697969 ↗
• InjuryApr 20, 2021Break; Break

  IT WAS REPORTED THAT NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE GUIDEWIRE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 405079; BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE 3 CM WHITACRE SPINAL NEEDLE TIP THAT BROKE OFF AT TIME OF SPINAL BLOCK AT BEGINNING OF TOTAL HIP REPLACEMENT. VERBATIM: WE ARE IN THE PROCESS OF A COMPLETING A MEDWATCH REPORT, WHICH WILL DETAIL THE OCCURRENCE. 65 YEAR-OLD FEMALE PATIENT. ADDITIONAL LENGTH OF SURGERY TIME (AROUND 50 MINUTES ADDITIONAL OR TIME AFTER COMPLETION OF SCHEDULED TOTAL HIP REPLACEMENT); ADDITIONAL SURGICAL PROCEDURE BY SPINE SURGEON TO REMOVE UNINTENTIONALLY RETAINED 3 CM WHITACRE SPINAL NEEDLE TIP THAT BROKE OFF AT TIME OF SPINAL BLOCK AT BEGINNING OF TOTAL HIP REPLACEMENT. PATIENT REMAINS IN-PATIENT AT HOSPITAL S/P TOTAL HIP REPLACEMENT SURGERY. ADDITIONAL INFORMATION WILL BE IN MEDWATCH REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697806 ↗
• InjurySep 23, 2019Break; Break

  IT HAS BEEN REPORTED THAT ONE NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE HAS BEEN FOUND WITH THE NEEDLE BREAKING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PATIENT WHO PRESENTS SPINAL NEEDLE FRACTURE AT THE TIME OF SPINAL ANESTHESIA. REQUIRED: NEUROSURGEON EVALUATION, POSITION WITH FLUOROSCOPE IS VERIFIED, INCISION IS MADE, THE FRAGMENT IS REMOVED AND SKIN IS SUTURED. THE HOSPITAL STAY IS NOT PROLONGED OR THE PATIENT'S INITIAL MANAGEMENT PLAN IS CHANGED. HE LEAVES THE INSTITUTION ON THE SAME DAY AND INFORMS THE PATIENT AND FAMILY OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9106710 ↗