BD Microtainer® Contact-Activated Lancet 366594Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 30382903665946), received between Oct 27, 2017 and Jan 6, 2026 — classified as 10 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT WHEN USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE UNIT FAILED TO RETRACT AFTER PRESSING THE BUTTON. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974027 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT WHEN USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, A PIECE OF THE LANCET BROKE OFF IN THE PATIENT'S FINGER. THE PIECE OF THE LANCET WAS REMOVED USING TWEEZERS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452261 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT WHEN USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE BLADE BROKE OFF IN THE CUSTOMER'S FINGER AND WAS REMOVED USING TWEEZERS. NO MEDICAL INVENTION WAS REPORTED. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310660 ↗
• MalfunctionAug 20, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BEFORE USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE DATES ON THE CERTIFICATE OF ANALYSIS DOES NOT MATCH THE DATES ON THE PRODUCT LABELING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853249 ↗
• MalfunctionAug 20, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BEFORE USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE DATES ON THE CERTIFICATE OF ANALYSIS DOES NOT MATCH THE DATES ON THE PRODUCT LABELING. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853243 ↗
• InjuryJul 29, 2025Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT AFTER USING ONE (1) BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE PATIENT DEVELOPED AN INFECTION REQUIRING HOSPITALIZATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. REPORTED VERBATIM: "THE PATIENT DEVELOPED INFECTION AFTER USING NEEDLE 366594, LOT NO B3D51H7 ADMITTED TO HOSPITAL ON (B)(6) 2025. THE PATIENT WAS ADMITTED WITH RIGHT MIDDLE FINGER CELLULITIS FOLLOWING A FINGER PRICK TEST AT HOME. HE WAS TREATED WITH IV ANTIBIOTICS AND HAND ELEVATION AND DISCHARGED."

  Patient problems: Bacterial Infection

  MAUDE report 22649018 ↗
• InjuryAug 5, 2024Break; Break

  IT WAS REPORTED WHILE USING A BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE LANCET BROKE WHILE PUNCTURING THE FINGER. THIS RESULTED IN METAL AND PLASTIC FRAGMENTS BEING LEFT IN THE FINGER. PATIENT WENT TO A HEALTH CENTER TO HAVE THE METAL AND PLASTIC FRAGMENTS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19914574 ↗
• MalfunctionApr 4, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE CAP WAS LOOSE ON ONE (1) DEVICE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043301 ↗
• InjuryNov 30, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT AFTER PATIENT'S FINGER WAS PUNCTURED WITH THE BD MICROTAINER® CONTACT-ACTIVATED LANCET, A SMALL PIECE OF METAL BROKE OFF INTO PATIENT'S FINGER. PATIENT COMPLAINED OF PAIN AT THE SITE OF THE PUNCTURE AFTER THE FINGERSTICK. PATIENT SUBSEQUENTLY HAD AN X-RAY WHICH REVEALED THERE WAS A PIECE OF METAL IN HER FINGER. PATIENT THEN HAD A SURGICAL PROCEDURE TO HAVE PIECE OF METAL REMOVED AND WAS TREATED WITH ANTIBIOTICS. VERBATIM: "CUSTOMER REPORTING THAT A SMALL PIECE OF METAL BROKE OFF INTO THE PATIENTS FINGER AFTER THE FINGER WAS PUNCTURED WITH THE LANCET. THE PATIENT COMPLAINED OF PAIN AFTER THE FINGERSTICK AT THE SITE OF THE PUNCTURE. PATIENT SUBSEQUENTLY HAD AN X-RAY WHICH REVEALED THERE WAS A PIECE OF METAL IN HER FINGER. SHE THEN HAD SURGERY TO HAVE THE PIECE OF METAL REMOVED AND WAS TREATED WITH ANTIBIOTICS".

  Patient problems: Needle Stick/Puncture

  MAUDE report 18241796 ↗
• InjuryNov 28, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET A CUSTOMER GOT HER FINGER STUCK WHILE PICKING UP THE TRASH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT SHE STUCK HER FINGER WITH A DISCARDED BLUE AND WHITE BD CONTACT ACTIVATED LANCET WHILE PICKING UP TRASH. WAS IT A CLEAN NEEDLE OR A USED NEEDLE: DIRTY DISCARDED NEEDLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18216876 ↗
• MalfunctionOct 11, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT WHILE USING BD MICROTAINER® CONTACT-ACTIVATED LANCET THAT THERE WAS A LANCET BREAK OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAGE: DURING USE. DEFECT: IN THE BLOOD COLLECTION ROOM OF THE PEDIATRIC CLINIC, AFTER PRESSING THE BLOOD COLLECTION BUTTON, ALL PARTS OF THE BLOOD COLLECTION DEVICE COLLAPSED AND POPPED OUT. QUANTITY: 1 PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911742 ↗
• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED THAT WHILE USING BD MICROTAINER® CONTACT-ACTIVATED LANCET THAT THE LANCET BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD AN INCIDENT WHERE A USER USED A LANCET AND IT SNAPPED AND WENT TO THEIR FINGER. THEY WERE ABLE TO TAKE THE FRAGMENT OUT OF THEIR FINGER WITH A TWEEZER."

  Patient problems: Laceration(s)

  MAUDE report 17494546 ↗
• MalfunctionMay 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHILE USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT: NON-COMPLIANCE OF THE LABELING FOR BD PRODUCTS SHIPPED TO UKRAINE (LABELING NOT COMPLIANT WITH LOCAL/UKRAINIAN REQUIREMENTS) AFFECTED BD PRODUCTS: IDS SM (PLEASE FIND ATTACHMENT#1. WITH THE LIST OF AFFECTED SKUS IDENTIFIED BY OUR TEAM) LEGAL MANUFACTURER: BECTON, DICKINSON AND COMPANY, 1 BECTON DRIVE, FRANKLIN LAKES, NJ 07417-1855, USA DESCRIPTION: WE DISCOVERED THAT SOME OF THE IFUS FOR IDS SM PRODUCTS ARE NOT COMPLIANT WITH UKRAINIAN REQUIREMENTS. IDS SM PRODUCTS OF HIGHER CLASSES (INCLUDED ATTACHMENT#1.) WERE REGISTERED VIA CONFORMITY ASSESSMENT BODY IN UKRAINE. WHEN PRODUCT IS REGISTERED VIA CONFORMITY ASSESSMENT BODY IT IS REQUIRED TO HAVE IT INDICATED ON THE LABELS AND IFUS (CONFORMITY ASSESSMENT BODY NUMBER MUST BE PLACED ON THE LABELING) ¿ IT MUST BE PLACED UNDERNEATH THE UKRAINIAN CONFORMITY MARK. UKRAINIAN CONFORMITY MARK: UKRAINIAN CONFORMITY MARK WITH CONFORMITY ASSESSMENT BODY NUMBER: AS AN EXAMPLE PLEASE SEE BELOW THE NEW IFU FOR SKU 367300 (PLEASE FIND ENCLOSED ATTACHMENT#2.) WHICH WAS R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000057 ↗
• MalfunctionMay 2, 2023Defective Device; Defective Device

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET THE LANCET BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE LANCET DISASSEMBLED COMPLETELY INTO 5 PIECES WHILE TAKING THE SAMPLE. NO INJURIES OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854141 ↗
• MalfunctionMar 2, 2023Device Contamination with Chemical or Other Material; Material Deformation; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET THERE WAS FOREIGN MATTER ON THE DEVICE NEEDLE/BLADE AND MOLDING DEFECT (SHORT SHOT). THE FOREIGN MATTER EVENT OCCURRED 84 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS THE FOLLOWING ISSUES FOR THE LANCET: (1) FM -DIRT ×84. (2) MOLDING DEFECT OF SHIELD (BLUE PART) ×1."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16467662 ↗
• MalfunctionDec 19, 2022Break; Material Fragmentation; Separation Problem; Break; Material Fragmentation; Separation Problem

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET THE LANCET BREAKS OFF AND THERE IS A RETRACTION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "LANCET LEFT THE METAL LANCET WITHIN THEIR FINGER AFTER USE." THERE WAS NO FURTHER REPORT OF INJURY OR REQUIRED MEDICAL INVENTIONS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010026 ↗
• MalfunctionNov 21, 2022Break; Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET THERE WAS FOREIGN MATTER. THIS EVENT OCCURRED 24 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿THE CUSTOMER REPORTED THE FOLLOWING ISSUES OF LANCET (CAT#366594). (1) DAMAGED SHIELD (BLUE COMPONENT) ×1. (2) DAMAGED/CRACKED HOUSING (WHITE COMPONENT) ×4. (3) FM (DIRT) ×24."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15839106 ↗
• MalfunctionNov 3, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿ TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE TUBES ARE UNDERFILLING. FROM A BD SPONSORED CLINICAL TRIAL, THE SPECIMEN STOPPED FLOWING INTO TUBE. CUSTOMER STATED THE SPECIMEN WAS BELOW THE BOTTOM FILL LINE. THERE WAS NO REPORTED PATIENT ADVERSE EVENT(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15719475 ↗
• MalfunctionOct 20, 2022Break; Premature Separation; Break; Premature Separation

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE DEVICE EXPERIENCED THE LANCET BREAKING OFF. THIS EVENT OCCURRED ONCE. THERE IS NO MENTION OF MEDICAL INTERVENTION OR REMOVAL TYPE OF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE¿VE HAD A CUSTOMER RAISE AN ISSUE WHERE THE TIP OF A LANCE HAS BROKEN OFF IN A PATIENT¿S HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642138 ↗
• MalfunctionSep 5, 2022Retraction Problem; Defective Component; Improper Flow or Infusion; Retraction Problem; Defective Component; Improper Flow or Infusion

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET LANCET DID NOT ACTIVATE, THE NEEDLE WAS NOT RECOVERED. THIS EVENT OCCURRED 200 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING USING THE LANCET, IT WAS FOUND THAT THE LANCET DID NOT ACTIVATE, THE NEEDLE WAS NOT RECOVERY, AND OCCURRED INSUFFICIENT BLOOD FLOW ISSUE. PATIENTS AND USERS WERE NOT AFFECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15358920 ↗
• MalfunctionSep 2, 2022Defective Component; Defective Component

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET THERE WAS A RETRACTION ISSUE, DELAY OR NO RETRACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE BLADE OF THE LANCET DID NOT COME OUT UPON VENIPUNCTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351122 ↗
• MalfunctionAug 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT BD MICROTAINER® CONTACT-ACTIVATED LANCET HAD DELATED ACTIVATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THROUGH THE RESULTS OF A BD SPONSORED CLINICAL TRIAL (B)(4), WE RECENTLY BECAME AWARE THAT THE FOLLOWING EVENT OCCURRED DURING A BLOOD COLLECTION FOR SUBJECT 6-S308 : LANCET DOES NOT RETRACT AFTER COLLECTION. TWO LANCETS DID NOT DEPLOY ON THE SUBJECT'S FINGER. 3RD WAS A SUCCESS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15251095 ↗
• MalfunctionJun 8, 2022Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET HCP WAS CURIOUS AND POKED HERSELF WITH A NEW LANCET, AND IT LEFT A SHARD OF METAL IN HER FINGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "MY LEAD OBTAINED A BLOOD SUGAR ON A PATIENT WITH ONE OF THE NEW LANCETS AND THE PATIENT COMPLAINED OF PAIN AND IT BLED MUCH MORE THAN NORMAL. MY LEAD WAS CURIOUS SO SHE POKED HERSELF WITH A NEW ONE AND IT LEFT A SHARD OF METAL IN HER FINGER. THE SIZE OF THESE NEW NEEDLES ARE MUCH LARGER THAN THE PREVIOUS. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633716 ↗
• MalfunctionJun 7, 2022Defective Device; Defective Device

  IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE DEVICE EXPERIENCED LANCET BREAKS OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THE LANCET HAD TIP BROKEN AFTER BLOOD COLLECTION. ONE OF THE LEAD'S PROCEEDED TO POKE HERSELF WITH ONE OF THE NEW LANCETS AND IT LEFT A SHARD OF METAL IN HER FINGER STATING THAT THE NEW NEEDLES ARE LARGER THAN THE PREVIOUS. "MY LEAD OBTAINED A BLOOD SUGAR ON A PATIENT WITH ONE OF THE NEW LANCETS AND THE PATIENT COMPLAINED OF PAIN AND IT BLED MUCH MORE THAN NORMAL. MY LEAD WAS CURIOUS SO SHE POKED HERSELF WITH A NEW ONE AND IT LEFT A SHARD OF METAL IN HER FINGER. THE SIZE OF THESE NEW NEEDLES ARE MUCH LARGER THAN THE PREVIOUS. " CUSTOMER PROBLEM: CUSTOMER REPORTS A LANCET WITH THE TIP BROKEN OFF AFTER BLOOD COLLECTION. A SMALL PIECE OF METAL BROKE OFF FROM THE TIP OF THE LANCET DURING BLOOD COLLECTION. DID EXPOSURE TO BLOOD/ BF OCCUR? NO IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14627143 ↗
• MalfunctionJun 2, 2022Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A BD SPONSORED CLINICAL TRIAL THE BD MICROTAINER® CONTACT-ACTIVATED LANCET DID NOT ACTIVE DURING BLOOD COLLECTION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT DURING A CLINICAL TRAIL DURING BLOOD COLLECTION THE LANCET DID NOT ACTIVATE. THE LANCET DEPLOYMENT WAS HEARD BUT PATIENT DID NOT FEEL A PUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575404 ↗