BD Vacutainer® Luer-Lok™ Access Device Holder 364902Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 50382903649025), received between Oct 17, 2017 and Nov 22, 2024 — classified as 4 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (37 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K991088); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jan 6, 2022Class IIIOpen, Classified

   May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts

   Z-0665-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER THAT AN UNSPECIFIED NUMBER OF DEVICES HAD INSUFFICIENT BLOOD FLOW WHEN USED IN CONJUNCTION WITH AN IMPLANTED CATHETER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20765951 ↗
• MalfunctionMar 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER, THERE WAS BLOOD LEAKAGE. NO REPORT OF ADVERSE OR INJURY TO PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995418 ↗
• MalfunctionAug 15, 2023Component Incompatible; Component Incompatible

  (B)(6) : 2023-09-01 13:09:23 (GMT). REVIEWED, PENDING INVESTIGATION SUMMARY. (B)(6) : 2023-08-28 19:38:17 (GMT). CUSTOMER DID NOT RESPOND AFTER MULTIPLE ATTEMPTS TO CONTACT FOR RETURNS. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(6) : 2023-08-23 13:25:51 (GMT). SUBJECT: EMAIL 8/23/2023, 8:23:02 AM USER: (B)(6) CREATED ON: 2023-08-23 13:23:02 CALL ACTIVITY COMMENT: FINAL FOLLOW UP FOR RETURNS. KIMBERLY JACKSON : 2023-08-21 12:29:57 (GMT). SUBJECT: EMAIL 8/21/2023, 7:25:23 AM. USER: (B)(6). CREATED ON: 2023-08-21 12:25:24. CALL ACTIVITY COMMENT: 1ST FOLLOW UP FOR RETURNS. (B)(6): 2023-08-17 12:22:45 (GMT). SUBJECT: EMAIL 8/17/2023, 7:00:29 AM. USER: (B)(6). CREATED ON: 2023-08-17 12:00:30. CALL ACTIVITY COMMENT: FEDEX RETURN LABEL SENT. KIMBERLY JACKSON : 2023-08-17 12:10:59 (GMT) FEDEX RETURN: 773081660949 (B)(6) : 2023-08-16 17:49:25 (GMT). SUBJECT: EMAIL 8/16/2023, 12:16:59 PM. USER: (B)(6). CREATED ON: 2023-08-16 17:17:00. CALL ACTIVITY COMMENT: FINAL REQUEST IF RETURNS ARE AVAILABLE (B)(6) : 2023-08-14 16:54:51 (GMT). SUBJECT: EMAIL 8/14/2023, 9:54:16 AM. USER: (B)(6) CREATED ON: 2023-08-14 14:54:16 CALL ACTIVITY COMMENT: ASKED IF RETURNS AVAILABLE (B)(6) : 2023-08-14 15:26:02 (

  Patient problems: Insufficient Information

  MAUDE report 17549552 ↗
• MalfunctionAug 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER THAT THERE WAS POOR SLEEVE FUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS REPORT IS ABOUT BLOOD LEAK. WHEN THE PRODUCT WAS USED FOR DISPENSING, THE RUBBER SLEEVE ON THE NEEDLE DID NOT RETURN PROPERLY AND BENT. BLOOD LEAKED FROM THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466874 ↗
• MalfunctionJun 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K LUER LOCK THERE WAS BLOOD SPILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE CUSTOMER COMPLAINED THAT THERE WAS BLOOD SPILLAGE DURING SAMPLING AT THE CONNECTING PART OF THE NEEDLE AND HOLDER INSIDE THE LUER-LOK ACCESS DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213184 ↗
• MalfunctionJun 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER WAS SPRAYING BLOOD FROM DEVICE DURING BLOOD COLLECTION. THIS REPORT IS TO CAPTURE THE INCIDENT WITH THE UNKNOWN DATE AND LOT #. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVING CONSTANT ISSUE WITH LOT#: 3009386. "BLOOD IS SPRAYING FROM DEVICE DURING BLOOD COLLECTION. WHILE COLLECTING BLOOD FROM A VENOUS NON-VALUED VASCULAR ACCESS DEVICE, USING A TRANSFER DEVICE (VACUTAINER) DIRECTLY CONNECTED TO A CLEAR-LINK CONNECTOR VIA LEURLOCK AND LABORATORY TUBE INSERTED INTO PUNCTURE SIDE OF THE VACUTAINER, BLOOD SPRAYED ONTO THE WALL AND APPROXIMATELY 3 FEET ACROSS ROOM DURING COLLECTION, SUSPECTED THAT IT OCCURRED WHEN REMOVING COLLECTION TUBE FROM VACUTAINER DEVICE. THIS SAME EVENT OCCURRED A WEEK PRIOR WITH ANOTHER PATIENT, ANOTHER TYPE OF COLLECTION TUBE, AND ANOTHER STAFF MEMBER PERFORMING THE DRAW. WE CANNOT CONFIRM THIS VACUTAINER LOT NUMBER WAS INVOLVED IN THIS PREVIOUS EVENT." WAS THERE BLOOD EXPOSURE? INFORMATION NOT AVAILABLE IF YES, WHERE DID THE EXPOSURE OCCUR TO? (WAS IT THE EYE, MOUTH, OPEN CUT, ETC) INFORMATION NOT AVAILABLE. WAS MEDICAL INTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209744 ↗
• MalfunctionJun 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER WAS SPRAYING BLOOD FROM DEVICE DURING BLOOD COLLECTION. THIS REPORT IS TO CAPTURE THE INCIDENT FROM 05/24/2023 AND LOT # 3009386. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVING CONSTANT ISSUE WITH LOT#: 3009386. "BLOOD IS SPRAYING FROM DEVICE DURING BLOOD COLLECTION. WHILE COLLECTING BLOOD FROM A VENOUS NON-VALUED VASCULAR ACCESS DEVICE, USING A TRANSFER DEVICE (VACUTAINER) DIRECTLY CONNECTED TO A CLEAR-LINK CONNECTOR VIA LEURLOCK AND LABORATORY TUBE INSERTED INTO PUNCTURE SIDE OF THE VACUTAINER, BLOOD SPRAYED ONTO THE WALL AND APPROXIMATELY 3 FEET ACROSS ROOM DURING COLLECTION, SUSPECTED THAT IT OCCURRED WHEN REMOVING COLLECTION TUBE FROM VACUTAINER DEVICE. THIS SAME EVENT OCCURRED A WEEK PRIOR WITH ANOTHER PATIENT, ANOTHER TYPE OF COLLECTION TUBE, AND ANOTHER STAFF MEMBER PERFORMING THE DRAW. WE CANNOT CONFIRM THIS VACUTAINER LOT NUMBER WAS INVOLVED IN THIS PREVIOUS EVENT." WAS THERE BLOOD EXPOSURE? INFORMATION NOT AVAILABLE. IF YES, WHERE DID THE EXPOSURE OCCUR TO? (WAS IT THE EYE, MOUTH, OPEN CUT, ETC) INFORMATION NOT AVAILABLE. WAS MEDICAL IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209743 ↗
• MalfunctionJun 20, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER THAT THE DEVICE MALFUNCTION, AND NEEDLE BROKE OFF CAUSING A SPILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE ACCESS DEVICE MALFUNCTION DURING BLOOD COLLECTION FROM A CENTRAL LINE, NEEDLE BREAK OFF AND BLOOD SPILL NON-STOP FROM CENTRAL LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164086 ↗
• MalfunctionJun 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS BLOOD SPILLAGE/LEAKS FROM THE BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER. VERBATIM: HAVING AN ISSUE OF BLOOD SPILLAGE/LEAKS FROM THE BLUE TOP WILL BE VISITING THE ACCOUNT TOMORROW FOR TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159708 ↗
• InjuryMay 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER LEAKAGE/SPLATTER OCCURRED WHEN REMOVING THE VACUTAINER. BLOOD SPLATTER WENT INTO RN'S EYES. PATIENT HAD LABS DRAWN TO TEST FOR HIV, HEP B AND HEP C. RN FLUSHED OUT HIS EYES WITH WATER FOR AT LEAST 5 MINUTES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WE HAD ANOTHER OCCURRENCE OF POSSIBLE BD LUER-LOK ACCESS DEVICE MALFUNCTION BUT THIS TIME WITH A TRUE BLOOD EXPOSURE, WHICH HAS NOT HAPPENED IN THE PAST. THE PACKAGING WITH THE LOT AND REFERENCE NUMBER WERE TOSSED BEFORE THE INCIDENT SO WE DO NOT HAVE THOSE NUMBERS." -WHERE SPECIFICALLY WAS THE LEAKAGE? IN THIS CASE, THE RN REPORTED THE FOLLOWING: "I WAS IN THE PROCESS OF REMOVING A VACUTAINER AFTER DRAWING LABS AND AS I REMOVED IT BLOOD SPLATTERED OUT OF THE VACUTAINER/IV PIGTAIL. I WAS SURPRISED AT THE AMOUNT OF BLOOD THAT HAD SPLATTERED OUT BECAUSE I WAS NOT USED TO SEEING THAT MUCH COME OUT AFTER REMOVING THE VACUTAINER. THE BLOOD SPLATTERED INTO MY FACE AND MY EYES. I FLUSHED OUT MY EYES WITH WATER FOR AT LEAST 5 MINUTES AND REPORTED THE INCIDENT TO MY CHARGE NURSE, SUPERVISOR, AND NUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035199 ↗
• MalfunctionMay 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER IT WAS DISCOVERED THAT THE IFU'S WERE NOT COMPLIANT WITH UKRAINIAN REQUIREMENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE DISCOVERED THAT SOME OF THE IFUS FOR IDS SM PRODUCTS ARE NOT COMPLIANT WITH UKRAINIAN REQUIREMENTS. IDS SM PRODUCTS OF HIGHER CLASSES 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: ALSO, WE WOULD LIKE TO POINT OUT THAT IN THE PROCEDURE ¿MEDICAL DEVICE AND IN VITRO DIAGNOSTIC MEDICAL DEVICE REQUIRED LABELING CONTENT¿USED BY THE LABELING TEAM THIS REQUIREMENT IS NOT CAPTURED. THEREFORE, THE SOP ALSO NEEDS TO BE UPDATED AND IMPLEMENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16999994 ↗
• MalfunctionMay 15, 2023Leak/Splash; Product Quality Problem; Leak/Splash; Product Quality Problem

  IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ ACCESS DEVICE THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP AND THE HUB SEPARATED FROM THE DEVICE. THE LEAKAGE EVENT OCCURRED 2 TIMES. THE HUB SEPARATION ISSUE OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER REPORTED ISSUES OF BLOOD LEAKING FROM THE HUB DURING BLOOD DRAW X 2 AND 1 INSTANCE WHERE THE HUB SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936382 ↗
• MalfunctionApr 11, 2023Filling Problem; Leak/Splash; Filling Problem; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED MULTIPLE SAMPLE ADAPTER THERE WAS A LOW DRAW AND WHEN REMOVING TUBE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER CUSTOMER'S REPORT, "WHEN VACUTAINER LUER-LOK ACCESS DEVICE ATTACHED TO IV TUBING TO OBTAIN LABS, BLOOD RETURN SLOW AND THEN WHEN TAKING OFF BLOOD COLLECTION TUBE, BLOOD KEPT COMING OUT AND SATURATED THE INSIDE OF THE VACUTAINER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713678 ↗
• MalfunctionApr 5, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ ACCESS DEVICE THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER RN PULLED OFF VIAL, BLOOD WAS COMING OUT OF NEEDLE ALL OVER THE FLOOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686431 ↗
• MalfunctionMar 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ ACCESS DEVICE THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE VACUTAINER WAS BROKEN WHEN THE SPECIMEN TUBE WAS INSERTED. WHEN THE VACUTAINER WAS REMOVED BLOOD POURED ONTO FLOOR. PRODUCT IS LEAKING FROM INNER HUB WHEN CHANGING/REMOVING VACUTAINERS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587484 ↗
• MalfunctionFeb 14, 2023Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ ACCESS DEVICE THE TUBE WAS UNABLE TO BE FILLED COMPLETELY. THIS EVENT OCCURRED 8 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE LLAD CANNULA CAUSED IN SIDEWALL PUNCTURE OF THE CPT PRODUCT RESULTING IN A LOW DRAW. OUT OF 450 DRAWS USING THE GUIDED DRAW SYSTEM, 8 SIDEWALL PUNCTURES OCCURRED DURING TEST METHOD DEVELOPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372360 ↗
• MalfunctionDec 29, 2022Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K LUER LOCK STARTS TO LEAK FROM THE RUBBER PIECE INSIDE THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "PER CUSTOMER, WHEN DRAWING BLOOD FROM AN IV SITE, THE BD VACUTAINER LUER LOCK ACCESS DEVICE STARTED TO LEAK BLOOD FROM THE RUBBER PIECE INSIDE AFTER REMOVING THE TUBE FROM THE DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068414 ↗
• MalfunctionDec 9, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD LUER-LOK ACCESS DEVICE, THE DEVICE EXPERIENCED BLOOD SPLATTER /LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN FROM THE NON-PATIENT END NEEDLE/SLEEVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PATIENT 3 OF 3 CUSTOMER CONFIRMED IT WAS 3 INDIVIDUALS AFFECTED. CUSTOMER STATES BLOOD FLOWS FROM DEVICE WHEN ATTACHING THE VACUTAINER.

  Patient problems: Exposure to Body Fluids

  MAUDE report 15954580 ↗
• MalfunctionDec 9, 2022Fluid/Blood Leak

  WHEN DRAWING THE PATIENT'S BLOOD, THE BLOOD CAME OUT WHERE THE HUB OF THE VACUTAINER AND BUTTERFLY MEET. THEY WERE FULLY SCREWED TOGETHER. A PICTURE WAS TAKEN IF NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949849 ↗
• MalfunctionDec 8, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD LUER-LOK ACCESS DEVICE, THE DEVICE EXPERIENCED BLOOD SPLATTER /LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN FROM THE NON-PATIENT END NEEDLE/SLEEVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PATIENT 2 OF 3 CUSTOMER CONFIRMED IT WAS 3 INDIVIDUALS AFFECTED. CUSTOMER STATES BLOOD FLOWS FROM DEVICE WHEN ATTACHING THE VACUTAINER.

  Patient problems: Exposure to Body Fluids

  MAUDE report 15945676 ↗
• MalfunctionNov 29, 2022Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ ACCESS DEVICE (MALE LUER) THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE IS LEAKING AT THE NEEDLE WHILE CHANGING TUBES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15879306 ↗
• MalfunctionOct 19, 2022Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ ACCESS DEVICE (MALE LUER), THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHILST COLLECTING A PATIENT SAMPLE, THE LLAD WAS LEAKING FROM THE 18G NEEDLE INSIDE THE HOLDER WHERE THE BLOOD TUBES ARE INSERTED. CUSTOMER COLLECTED 2-3 BLOOD TUBES AND NOT SURE WHETHER THIS IS CAUSED BY USER ERROR OR THE LLAD IS LEAKING. SHE DID NOTE THIS HAS HAPPENED IN 2 SEPARATE PATIENTS AND COULD BE A DEVICE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635251 ↗
• MalfunctionOct 11, 2022Fluid/Blood Leak

  IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ ACCESS DEVICE (MALE LUER) THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "THE LLAD DOES NOT FIT TIGHTLY, CAUSE BLOOD TO COME OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584165 ↗
• MalfunctionSep 19, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ ACCESS DEVICE THERE WAS INSUFFICIENT BLOOD FLOW THROUGH THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN USING, BLOOD CANNOT BE DRAWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447857 ↗
• MalfunctionSep 19, 2022Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ ACCESS DEVICE THERE WAS INSUFFICIENT BLOOD FLOW THROUGH THE DEVICE. THIS EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLOOD CANNOT BE DRAWN WHEN USING THE PUNCTURE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447747 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991088. One submission often covers many models, so check the product and lot details in each record.

• Z-0837-2022 · Feb 24, 2022 · Terminated
  Regard Custom Procedure Kits containing BD Luer Lok Access Devices
• Z-0253-2007 · Sep 8, 2006 · Terminated
  BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD Franklin Lakes,
• Z-1462-06 · Jun 21, 2006 · Terminated
  BD Vacutainer Luer Adapter; Catalog #367290 and #367300.