BD Nokor 305214Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903052141), received between Jan 11, 2019 and May 10, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL# 305214 BATCH# UNKNOWN IT WAS REPORTED BY CUSTOMER THAT THEY ARE HAVING ISSUES WITH THE NEEDLE CORING OUT THE VIAL STOPPER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REQUESTING IF WE HAVE RECOMMENDATIONS FOR A CUSTOMER THAT IS HAVING ISSUES USING THE NOKOR VENTED NEEDLE (REF 305214). THEY ARE HAVING ISSUES WITH THE NEEDLE CORING OUT THE VIAL STOPPER. THEY HAVE TO THEN PLACE ANOTHER NEEDLE TO FILTER OUT THE MATERIAL. ALSO, HAS QUESTIONS ON HOW THE NOKOR VENTED NEEDLES WORK.

  Patient problems: Insufficient Information

  MAUDE report 19285354 ↗
• MalfunctionMay 9, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305214 BATCH#: UNKNOWN IT WAS REPORTED BY CUSTOMER THAT THE CURRENT VENTED NEEDLE WE USE IS CAUSING A LOT OF WORK ON THE BACK END DUE TO IT CORING THE VIAL LEAVING THE PRODUCT CONTAMINATED AND THEREFORE IT HAS TO BE FILTERED. I THINK THERE IS A QUESTION ALSO ABOUT IF IT IS THE VIAL STOPPER, WE ARE HAVING ISSUES WITH. I NEED TO RULE OUT ONE. I THOUGHT WE COULD TRY ANOTHER NEEDLE TO SEE IF THAT HELPS. DO WE HAVE ANY OTHER VENTED NEEDLES LIKE THIS THAT WE USED TO HAVE? THAT SLIDE PART WAS SO HELPFUL IN COMPOUNDING AND USE WITH OUR REPEATER PUMP. I DON¿T THINK VERY MANY SITES USE THE REPEATER PUMPS LIKE WE DO. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. THE CURRENT VENTED NEEDLE WE USE IS CAUSING A LOT OF WORK ON THE BACK END DUE TO IT CORING THE VIAL LEAVING THE PRODUCT CONTAMINATED AND THEREFORE IT HAS TO BE FILTERED. I THINK THERE IS A QUESTION ALSO ABOUT IF IT IS THE VIAL STOPPER, WE ARE HAVING ISSUES WITH. I NEED TO RULE OUT ONE. I THOUGHT WE COULD TRY ANOTHER NEEDLE TO SEE IF THAT HELPS. DO WE HAVE ANY OTHER VENTED NEEDLES LIKE THIS THAT WE USED TO HAVE? THAT SLIDE PART WAS SO HELPFUL IN COMPOUNDING AND USE WITH OUR REPEATER

  Patient problems: Insufficient Information

  MAUDE report 19277173 ↗
• MalfunctionDec 7, 2023Defective Component; Defective Component

  NO ADDITIONAL INFORMATION RECEIVED. MATERIALS#: 305214, BATCH#: 317334.1 IT WAS REPORTED BY THE CUSTOMER THAT THE NOKOR NON-CORING VENTED NEEDLE IS CLASSIFIED AS A BLUNT FILL NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. QUESTION: CALLER STATES THEY USE THE NOKOR NON-CORING VENTED NEEDLE 305214. CALLER WAS ASKING IF THERE ARE ANYINSTRUCTIONS FOR HOW TO USE THE NOKOR NEEDLES. CALLER STATES THEY RECENTLY PURCHASED THESE TO HELP ELIMINATECORING IN THEIR VIALS. THEY USED THE NOKOR NEEDLE THIS MORNING AND ENDED UP HAVING CORING IN A THIRD OF THEIRVIALS LEADING TO STOPPER MATERIAL IN THE VIALS. CALLER PROVIDED THE LOT NUMBER 3173341. CALLER ALSO ASKING FOR ACOPY OF THE COA. RESPONSE: INFORMED CALLER THE NOKOR NON-CORING VENTED NEEDLE IS CLASSIFIED AS A BLUNT FILL NEEDLE. PRODUCT CODE 305214IS VENTED, MEANING IT HAS A SIDE PORT TO HELP VENT AND REDUCE VIAL PRESSURE. EMAILED THE BLUNT FILL USAGEGUIDELINES FOR REFERENCE. INFORMED CALLER I WILL SUBMIT THIS TO OUR PRODUCT COMPLAINTS TEAM FOR FURTHERINVESTIGATION. INFORMED CALLER THE COA CAN BE LOCATED ON THE BD REGULATORY SITE. PRODUCT/MODELNUMBER: 305214.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282611 ↗
• MalfunctionJun 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE NEEDLES ARE CORING PRIOR TO USE WITH A BD NEEDLE VENTED NOKOR 18X1 TW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED NEEDLES ARE CORING.

  Patient problems: No Patient Involvement

  MAUDE report 10131438 ↗
• MalfunctionJan 11, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOUR OF THE BD NOKOR¿ FILTER AND ADMIX NEEDLES EXPERIENCED COMPROMISED STERILITY FROM FOREIGN MATTER.

  Patient problems: No Information

  MAUDE report 8240993 ↗