N/A 302890Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 50382903028905), received between Sep 11, 2018 and Sep 16, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 reports).

3 other recalls cover devices cleared under the same FDA submission (K021475); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794662 ↗
• MalfunctionSep 16, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794660 ↗
• MalfunctionApr 12, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 302890, BATCH#: 3198062. IT WAS REPORTED BY THE CUSTOMER THAT EPOXY IN FLUID PATH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE ARE HAVING MORE ISSUES WITH PN 302890, SPECIFICALLY EPOXY IN FLUID PATH. I HAVE ALREADY WRITTEN THE COMPLAINT DEPARTMENT BUT HAVE NOT RECEIVED ANY RESPONSE. COMMENTS ON (B)(6) 2024. I WILL BE SENDING OUT THE SAMPLES THIS WEEK. COMMENTS ON (B)(6) 2024. 1) BATCH NUMBER IS 3198062. 2) SAMPLES HAVE BEEN SENT . 3) WE HAVE SEEN THIS ISSUE SINCE (B)(6) 2023. 5) ISSUE DID NOT INVOLVE A PATIENT OR USER. 6) NO, EVENT HAS NOT INVOLVED LIFE THREATENING SITUATION. 7) WE HAVE HAD A MINIMUM OF 30 INSTANCES FOUND, POSSIBLY MORE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095653 ↗
• MalfunctionApr 5, 2024Complete Blockage; Complete Blockage

  ADDITIONAL INFORMATION RECEIVED STORAGE CONDITIONS ARE IN A DESIGNATED RAW MATERIAL STORAGE ROOM AT AMBIENT CONDITIONS. MATERIAL#: 30289; LOT#: 3198062. IT WAS REPORTED BY THE CUSTOMER THAT THEY INSPECTED TO DETERMINE IF THIS ISSUE WAS ACROSS MULTIPLE LOTS. WE HAVE FOUND A SIMILAR MATERIAL IN THE FLUID PATH OF THE CANNULA. A TOTAL OF 3 OUT OF 330 CANNULAS WERE FOUND WITH THIS ISSUE DURING INSPECTION, WE ARE NOT SURE THE TWO INSTANCES ARE RELATED BUT WANTED TO SHARE THIS FOR YOUR INFORMATION DURING YOUR INVESTIGATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED DUE TO THE ISSUE WITH THE 30G CANNULAS A MORE RECENT LOT (3198062) WAS INSPECTED TO DETERMINE IF THIS ISSUE WAS ACROSS MULTIPLE LOTS. WE HAVE FOUND A SIMILAR MATERIAL IN THE FLUID PATH OF THE CANNULA. A TOTAL OF 3 OUT OF 330 CANNULAS WERE FOUND WITH THIS ISSUE DURING INSPECTION, WE ARE NOT SURE THE TWO INSTANCES ARE RELATED BUT WANTED TO SHARE THIS FOR YOUR INFORMATION DURING YOUR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050565 ↗
• MalfunctionMar 12, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL#: 302890 LOT#:3052475 IT WAS REPORTED BY THE CUSTOMER THAT BEING CLOGGED BY THE END USER VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED OVER THE LAST FEW MONTHS WE HAVE HAD SEVERAL COMPLAINTS REGARDING PN 302890 (SPECIFICALLY FROM PO 106451) BEING CLOGGED BY THE END USER. WE WOULD APPRECIATE IF SOMEONE COULD LOOK INTO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884761 ↗
• MalfunctionMar 12, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 302890, LOT#:3052475 IT WAS REPORTED BY THE CUSTOMER THAT BEING CLOGGED BY THE END USER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED OVER THE LAST FEW MONTHS WE HAVE HAD SEVERAL COMPLAINTS REGARDING PN 302890 (SPECIFICALLY FROM (B)(4)) BEING CLOGGED BY THE END USER. WE WOULD APPRECIATE IF SOMEONE COULD LOOK INTO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884757 ↗
• MalfunctionMar 12, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL#: 302890, LOT#:3052475. IT WAS REPORTED BY THE CUSTOMER THAT BEING CLOGGED BY THE END USER: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) OVER THE LAST FEW MONTHS: WE HAVE HAD SEVERAL COMPLAINTS REGARDING PN 302890 (SPECIFICALLY FROM PO (B)(4) BEING CLOGGED BY THE END USER. WE WOULD APPRECIATE IF SOMEONE COULD LOOK INTO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18884751 ↗
• MalfunctionJul 22, 2022Contamination; Contamination

  IT WAS REPORTED THAT THE BD CLEAR HUB NEEDLE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER FOUND SOME ATTACHED FOREIGN MATTERS IN THE EPOXY PORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090039 ↗
• MalfunctionMay 11, 2022Break; Break

  IT WAS REPORTED WHILE USING BD NEEDLE 30GA 7/8IN BSG CLEAR HUB THE NEEDLE CANNULA BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:   IT WAS REPORTED BY THE CONSUMER BROKEN CANNULA. - CANNULA IS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 14365375 ↗
• MalfunctionJul 9, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 8 NEEDLES 30GA 7/8IN BSG CLEAR HUB EXPERIENCED LEAKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. (B)(6)BATCH NO. 9294128 PLEASE BE AWARE THAT WE HAVE REJECTED THE FOLLOWING LOT DUE TO DRIP OVER GREATER THAN 1/8" FROM THE NEEDLE TO THE PLASTIC HUB FLOWING THRU THE PLASTIC HUB RIBS. NON-CONFORMANCE DETECTED: 8 SAMPLES HAVE A DRIP OVER OF ABOUT 1/8" THAT STARTS FROM THE AREA WHERE THE NEEDLE AND THE PLASTIC HUB JOINS FLOWING TO THE PLASTIC HUB RIBS. THESE ARE NOT ACCEPTABLE. PER ANSI Z1.4 LEVEL II NORMAL AQL 0.65 PERFORMED THIS LOT WILL BE CONSIDERED REJECTED.

  Patient problems: No Patient Involvement

  MAUDE report 10254456 ↗
• MalfunctionFeb 20, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 5 NEEDLES 30GA 7/8IN BSG CLEAR HUB HAD EXCESSIVE EPOXY FOUND ON THEM, WHILE 16 NEEDLES WERE FOUND LACKING EPOXY. ALL DEFECTS WERE FOUND BEFORE USE IN LOT# 9294125 DURING AN INSPECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PART NUMBER 8029703 WITH LOT 9294125 WAS RECEIVED AND DURING THE INCOMING INSPECTION PROCESS THE PRODUCT IS BEING FOUND WITH 2 DIFFERENT DEFECTS EPOXY EXCESS AND LACK OF EPOXY." "TOTAL OF DEFECTS PIECES 21, 16 WITH LACK OF EPOXY & 5 WITH EXCESS OF EPOXY".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9733447 ↗
• MalfunctionAug 27, 2019Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash

  IT WAS REPORTED THAT NEEDLE 30GA 7/8IN BSG CLEAR HUB WAS OCCLUDED AND THE NEEDLE SEPARATED FROM THE SYRINGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 302890; BATCH NO. UNKNOWN (PROVIDED 7137558, 8145979, AND 7054534, STATED THIS NEEDLE WAS FROM ONE OF THE THREE LOTS PROVIDED). IT WAS REPORTED THE CANNULA IS OCCLUDED AND THE CANNULA SHOT OFF THE SYRINGE. NATURE OF INCIDENT: CANNULA IS OCCLUDED, CANNULA SHOT OFF THE SYRINGE EVALUATION: 1 SAMPLE WAS RETURNED TO BVI AND PRODUCT WAS TESTED PER CURRENT PROCESS FLOW TEST AND IT FAILED, ALSO TESTED WITH WATER AND ITS OCCLUDED, WHEN LOOKED THRU MICROSCOPE IT WAS POSSIBLE TO OBSERVE THAT BETWEEN THE END OF THE HUB AND THE BEGINNING OF THE NEEDLE THERE IS SOMETHING (NOT CLEAR OF WHAT THIS IS) BUT IT LOOKS LIKE ADHESIVE THAT IS OBSTRUCTING THE FLOW THRU THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8935156 ↗
• MalfunctionJul 11, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 425 NEEDLES 30GA 7/8IN BSG CLEAR HUB HAD EXCESSIVE EPOXY FOUND ON THEM BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY RECEIVED A CUSTOMER COMPLAINT RELATED TO NEEDLES WITH ¿DRIPOVER". OUR CUSTOMER RETURNED TO US 425 PIECES TAG AS DEFECTIVE. YOUR LOT IS 8284657.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781573 ↗
• MalfunctionApr 12, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ELEVEN NEEDLE 30GA 7/8IN BSG CLEAR HUB EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 302890, BATCH NO. 8284657. IT WAS REPORTED NEEDLES HAD EXCESS EPOXY. GOOD MORNING, ON (B)(6) 2019, WHILE PERFORMING INCOMING INSPECTION AUDIT FOR BD PART NO. 302890, LOT NO. 8284657. WITH AN INSPECTION AUDIT SPEC OF AQL 0.65 LEVEL II IT WAS FOUND 11 PARTS WITH EXCESS OF EPOXY, HAVING THESE RESULTS IT WAS DECIDED TO REJECT COMPLETE LOT. SAMPLES ARE AVAILABLE FOR YOUR EVALUATION, SO PLEASE HELP US TO SEND THE RMA FOR THE MATERIAL DESCRIBE BELOW. PART NO., LOT NO., BOXES QTY, QTY PER BOX, TOTAL, DEFECT, SUPPLIER: 8029703, 8284657, 7, 20,000, 140,000, EXCESS OF EPOXY, B-D.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8509246 ↗
• MalfunctionMar 12, 2019Defective Device

  IT WAS REPORTED THAT A NEEDLE 30GA 7/8IN BSG CLEAR HUB HAD EXCESSIVE FLASH ON THE HUB. THE FOLLOWING WAS REPORTED, MATERIAL NO. 302890 BATCH NO. 8145979. IT WAS REPORTED THERE IS EXCESSIVE FLASH ON HUBS. AS FEBRUARY 18, IT WAS RECEIVED PIR 74236 CUSTOMER COMPLAINT, DR. STATED ORDER OF ANTERIOR CHAMBER CANNULAS, 30GA, SEEMS TO HAVE EXCESSIVE FLASH ON THE HUBS. OFTEN ON ALL FOUR CORNERS OF THE HUB WITH SOME OF THE FLASH UP TO 4MM. WE ARE HAVING TO DEBURR THE HUBS AS WE WORK THROUGH THE INVENTORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8412755 ↗
• MalfunctionNov 8, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD¿ NEEDLE 30GA 7/8IN BSG CLEAR HUB CONTAINED FOREIGN MATTER, POSSIBLY EXCESS ADHESIVE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8052989 ↗
• MalfunctionOct 30, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS "EXCESS OF EPOXY" ON THE NEEDLE 30GA 7/8IN BSG CLEAR HUB. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8018946 ↗
• MalfunctionSep 11, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT BD¿ NEEDLE 30GA 7/8IN BSG CLEAR HUB CONTAINED FOREIGN MATTER DESCRIBED AS "EXCESS EPOXY". NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7865792 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021475. One submission often covers many models, so check the product and lot details in each record.

• Z-0588-2021 · Nov 18, 2020 · Terminated
  BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the bo
• Z-0207-2018 · May 31, 2017 · Terminated
  BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain bl
• Z-1009-2012 · Oct 8, 2011 · Terminated
  BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications