Port Access Needle 0131910Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741047329), received between Mar 12, 2020 and Aug 9, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 19, 2020Terminated

   Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

   Z-2670-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING OCCURRING WAS REPORTED AS A CHEMO SPILL AND EXPOSURE TO PATIENT AS WELL. PATIENT USUALLY REPORTED TO ANSWERING SERVICE AFTER HOURS OR WHEN PATIENT WAS COMING IN TO HAVE DISCONNECT AND WHITE POWDER RESIDUE WAS FOUND ON PATIENT¿S SKIN. NO INVOLVEMENT TO THE TUBING CONNECTED TO THE LOWER END OF THE PUMP AND NO MALFUNCTION OF THE PUMP. 5FU CHEMOTHERAPY.

  Patient problems: Insufficient Information

  MAUDE report 17494951 ↗
• MalfunctionAug 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING OCCURRING WAS REPORTED AS A CHEMO SPILL AND EXPOSURE TO PATIENT AS WELL. PATIENT USUALLY REPORTED TO ANSWERING SERVICE AFTER HOURS OR WHEN PATIENT WAS COMING IN TO HAVE DISCONNECT AND WHITE POWDER RESIDUE WAS FOUND ON PATIENT¿S SKIN. NO INVOLVEMENT TO THE TUBING CONNECTED TO THE LOWER END OF THE PUMP AND NO MALFUNCTION OF THE PUMP. 5FU CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494947 ↗
• MalfunctionAug 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING OCCURRING AS A CHEMO SPILL AND EXPOSURE TO PATIENT AS WELL. PATIENT USUALLY REPORTED TO ANSWERING SERVICE AFTER HOURS OR WHEN PATIENT WAS COMING IN TO HAVE DISCONNECT AND WHITE POWDER RESIDUE WAS FOUND ON PATIENT¿S SKIN. NO INVOLVEMENT TO THE TUBING CONNECTED TO THE LOWER END OF THE PUMP AND NO MALFUNCTION OF THE PUMP. 5FU CHEMOTHERAPY. PATIENT RECEIVED 100% OF CHEMO TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494946 ↗
• MalfunctionAug 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING OCCURRING WAS REPORTED AS A CHEMO SPILL AND EXPOSURE TO PATIENT AS WELL. PATIENT USUALLY REPORTED TO ANSWERING SERVICE AFTER HOURS OR WHEN PATIENT WAS COMING IN TO HAVE DISCONNECT AND WHITE POWDER RESIDUE WAS FOUND ON PATIENT¿S SKIN. NO INVOLVEMENT TO THE TUBING CONNECTED TO THE LOWER END OF THE PUMP AND NO MALFUNCTION OF THE PUMP. 5FU CHEMOTHERAPY.

  Patient problems: Insufficient Information

  MAUDE report 17494945 ↗
• MalfunctionAug 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING OCCURRING WAS REPORTED AS A CHEMO SPILL AND EXPOSURE TO PATIENT AS WELL. PATIENT USUALLY REPORTED TO ANSWERING SERVICE AFTER HOURS OR WHEN PATIENT WAS COMING IN TO HAVE DISCONNECT AND WHITE POWDER RESIDUE WAS FOUND ON PATIENT¿S SKIN. NO INVOLVEMENT TO THE TUBING CONNECTED TO THE LOWER END OF THE PUMP AND NO MALFUNCTION OF THE PUMP. 5FU CHEMOTHERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494943 ↗
• MalfunctionAug 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT CALLED INTO THE ANSWERING SERVICE AND THINKS THERE IS A SMALL LEAK FROM THE CHEMO PUMP. HE WAS ASKED TO COME TO THE ED IF HE WAS NOT ABLE TO REACH THE FACILITY SINCE IT IS LEAKING CHEMO. HE CALLED THE FACILITY, AND THEY TURNED IT OFF. HE CALLED BACK AND NOTED A SMALL SPILL ON THE CHEST AND HIS HAND FROM BEFORE. NO ISSUES ON THE CHEST, HIS HAND FELT SORE, SO HE PUT A BURN CREAM ON IT. I DISCUSSED THAT HE CAN EITHER GO TO THE ED FOR EVALUATION OR WAIT FOR CLINIC TO CONTACT HIM AND ARRANGE FOR HIM TO COME IN TODAY FOR PUMP EVALUATION. HE SAID HE WOULD RATHER DO THE LATTER SINCE HIS SYMPTOMS ARE FINE. PATIENT CAME IN AND WAS EVALUATED BY SENIOR NURSES IN THE PORT LAB. PATIENT IS OKAY. HERE IS SOME INFORMATION I OBTAINED FROM THE CLINICIAN ABOUT THIS PATIENT: LEAKAGE IS OCCURRING EITHER AT THE UPPER OR LOWER SITE OF THE TUBING WHERE IT CONNECTS TO THE NEEDLE OR TO THE FACILITY TUBING. I CAN CONFIRM WE HAD USED A 19G/ 1IN NEEDLE, UNFORTUNATELY THE NURSE ACCESSING THIS PATIENT'S PORT DID NOT CHART THE LOT NUMBER. THE LEAK OCCURRED ON THE BARD PORT NEEDLE IN THE TOP LUMEN WHERE THE CAP CONNECTS.

  Patient problems: Chemical Exposure

  MAUDE report 17494845 ↗
• MalfunctionAug 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING OCCURRING WAS REPORTED AS A CHEMO SPILL AND EXPOSURE TO PATIENT AS WELL. PATIENT USUALLY REPORTED TO ANSWERING SERVICE AFTER HOURS OR WHEN PATIENT WAS COMING IN TO HAVE DISCONNECT AND WHITE POWDER RESIDUE WAS FOUND ON PATIENT¿S SKIN. NO INVOLVEMENT TO THE TUBING CONNECTED TO THE LOWER END OF THE PUMP AND NO MALFUNCTION OF THE PUMP. 5FU CHEMOTHERAPY. IT IS UNKNOWN HOW MUCH OF CHEMO TREATMENT PATIENT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 17481060 ↗
• MalfunctionMar 9, 2023Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER "WE ARE HAVING ISSUES WITH OUR HUBER NEEDLES OF VARIOUS SIZES." THE EXACT QUANTITY OF NEEDLES WITH THIS ISSUE WASN'T REPORTED TO BD VASCULAR ACCESS DEPARTMENT BY THE CUSTOMER. 02/17/2023 - THE RETURNED NEEDLE EXHIBITED A CRACK.

  Patient problems: Insufficient Information

  MAUDE report 16510655 ↗
• MalfunctionDec 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WE HAVE HAD FOUR HUBER NEEDLES LEAK ON THE HUB END." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075099 ↗
• MalfunctionDec 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WE HAVE HAD FOUR HUBER NEEDLES LEAK ON THE HUB END." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075039 ↗
• MalfunctionDec 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WE HAVE HAD FOUR HUBER NEEDLES LEAK ON THE HUB END." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075014 ↗
• MalfunctionDec 29, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WE HAVE HAD FOUR HUBER NEEDLES LEAK ON THE HUB END." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16071065 ↗
• MalfunctionNov 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "OVER THE PAST TWO WEEKS WE HAD INCIDENCE OF A HUBER NEEDLE THAT WE USE IN PORT A CATHS LEAKING OUT OF PART OF THE TUBING ON THE DEVICE." ADDITIONAL INFORMATION "THE EVENT OCCURRED WITHIN 12 HOURS OF THE DEVICE BEING INSERTED INTO THE PATIENT AND WAS IDENTIFIED WHEN THE RN WAS FLUSHING THE Y PORT ON THE HUBER NEEDLE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882466 ↗
• MalfunctionOct 28, 2021Material Deformation; Material Deformation

  IT WAS REPORTED ¿NURSE WAS DE-ACCESSING VAD AND COULD NOT COMPLETELY REMOVE HUBER NEEDLE. CALLED CHARGE NURSE TO THE ROOM. THE CN STATED SHE COULD SEE "MEAT" HUNG UP ON THE NEEDLE SO, SHE MANEUVERED THE NEEDLE TO UNHOOK THE FLESH IT WAS PULLING ON THE WAY OUT. SHE WAS FINALLY ABLE TO DE-ACCESS THE VAD. STATED SHE COULD NOT ACTIVATE THE SAFETY ON THE NEEDLE DUE TO THE DEFORMITY OF THE NEEDLE. THIS COULD HAVE RESULTED IN A "REBOUND" NEEDLE STICK-(NEAR MISS). VAD INSERTED ON 3 SOUTH-DAY 0 ON (B)(6) 2021 AT 7:35. NOT SURE WHERE OR WHEN OR AT WHAT POINT THE NEEDLE WAS BENT.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713030 ↗
• MalfunctionJul 8, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED "I HAVE A CRACKED PORT FROM UNIT 7B. THE PORT IS CRACKED AT THE FIRST Y SITE CLOSEST TO THE NEEDLE. YOU CAN SEE THE CRACK ON THE PRODUCT WHEN IT IS IN FRONT OF YOU. I UNFORTUNATELY DO NOT HAVE THE LOT NUMBER OR THE REFERENCE NUMBER OF THE PRODUCT." ADDITIONAL INFO, RCVD 06/22/2021 "THERE WAS NO PATIENT HARM BUT I DO NOT HAVE ANY OTHER INFORMATION BESIDES THIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12137475 ↗
• MalfunctionMay 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PORT CAP POPPED OFF AND SPRAYED". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102173 ↗
• MalfunctionMar 12, 2020Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "RN ACCESSED PATIENT PORT AND AFTER THE NEEDLE WAS INSERTED, SHE FLUSHED AND THE WHITE CAP CLOSET TO THE NEEDLE/PATIENT FLEW OFF AND SALINE SPRAYED OUT ONTO THE PATIENT'S SHIRT. NORMAL FORCE WAS USED WHEN FLUSHING. PRODUCT: (POWER LOC MAX HUBER NEEDLE 19G 1 INCH, REF#: 0131910, LOT: ASDR075). CAP ON POWER LOC MAX HUBER NEEDLE TUBING PORT CLOSEST TO THE NEEDLE CAME OFF DURING FLUSHING. TUBING DID NOT APPEAR TO BE CRACKED, CAP DID NOT STAY ON AS IT NORMALLY DOES, MAY HAVE BEEN LOOSE OR DEFECTIVE. RN WAS ABLE TO PLACE ANOTHER STERILE CAP IN PLACE OF CAP THAT CAME OFF AND FINISHED FLUSHING PORT. NO PATIENT HARM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9825599 ↗