BD Perisafe™ 405148Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00382904051488), received between Jun 21, 2019 and Oct 15, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT NEEDLE SPINAL S/SU 22GA 5IN QUINCKE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT HAIR WAS FOUND IN SEALED PACKAGE OF THE SPINAL NEEDLE. EVENT DESCRIPTION: HELLO, I NEED TO REPORT A COMPLAINT ON A PRODUCT INVOLVING A HAIR FOUND IN PACKAGING OF A SPINAL NEEDLE. THE ISSUE WAS REPORTED YESTERDAY BY: (B)(6). THE COMPLAINT IS A HAIR WAS FOUND IN THE PACKAGING SPINAL NEEDLE, SEE ATTACHED PHOTOS. QUESTIONS/INQUIRIES: HOW MANY AFFECTED ITEMS INVOLVED? WHAT IS THE DATE OF THE EVENT? DO YOU HAVE SAMPLE(S) AVAILABLE THAT CAN BE SENT BACK FOR EVALUATION? IF SO, PLEASE AWAIT FOLLOW-UP EMAIL WHICH WILL CONTAIN INSTRUCTIONS AND PRE-PAID RETURN SHIPPING LABEL TO RETURN SAMPLES FOR INVESTIGATION.

  Patient problems: No Patient Involvement

  MAUDE report 10687882 ↗
• MalfunctionOct 3, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT HAS BEEN REPORTED THAT THE NEEDLE SPINAL S/SU 22GA 5IN QUINCKE HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF CONTAINING MIXED PRODUCT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT LABEL SHOWS NEEDLES ARE 22X5, HOWEVER NEEDLES INSIDE THE BOX ARE 22GX9.75. CMT: BOX SHOWS 22GX5 BUT INSIDE IS 22GX9.75.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9152155 ↗
• MalfunctionJul 29, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT SPINAL NEEDLE BD¿ QUINCKE STYLE 22 GAUGE 5 INCH LONG TYPE MAYO COVER WAS MISSING FROM THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 405148, BATCH NO. UNKNOWN (PROVIDED 17UB1623). IT WAS REPORTED THAT MAYO COVER WAS MISSING FROM THE PACKAGE. PER EMAIL: REPORTED ISSUE: PER REP/CUSTOMER NO MAYO COVER IN PACK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837718 ↗
• MalfunctionJun 21, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT TWO NEEDLES SPINAL S/SU 22GA 5IN QUINCKE EXPERIENCED INCORRECT LABEL INFORMATION DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 405148 BATCH NO: 8123938 LENGTH OF NEEDLES IS NOT WHAT IS ON THE BOX.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8722227 ↗