Port Access Needle 2205220Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741065866), received between Apr 26, 2018 and Sep 29, 2022 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER CRACKED TUBING BELOW THE Y AFTER 3 DAYS OF USE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502827 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE PORT NEEDLE CRACKED AT THE BASE OF THE CONNECTION TO THE Y WHERE THE EXTENSION SET STARTS. THE PRODUCT FAILS ON THE 2ND OR 3RD DAY OF USE. THE PRODUCT IS USED TO ACCESS A DUAL LUMEN PORT USED FOR TPN AND HYDRATION/MEDICATION DELIVERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434951 ↗
• MalfunctionAug 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA CHAT "ALL 5 GRIPPERS THAT I HAVE USED SO FAR LEAKS FROM A CRACK ON THE PLASTIC TUBING. WE RECEIVED A BOX OF GRIPPERS A WEEK AGO AND WE HAVE USED FIVE OF THE SO FAR. I RECEIVE SEVERAL DIFFERENT MEDICATION VIA PUMPS AND SYRINGES (PUSH). AFTER A FEW USES, A CRACK DEVELOPS AND MEDICATION LEAKS OUT. THE CRACK IS LOCATED IN THE CLEAR TUBING BETWEEN THE Y FITTING AND THE NEEDLE. THESE DEVISES WERE PURCHASE AT A LOCAL HOME CARE SERVICE PROVIDER IN CANADA. SO FAR EACH AND EVERY ONE OF THEM HAS FAILED AFTER 1 DAY OF USE.¿ ADD INFO REC'D 08/24/2022: IT WAS REPORTED BY MS&S " CONTACTED CUSTOMER OVER THE PHONE. WE DISCUSSED HIS SITUATION ¿ HE HAS A DAUGHTER THAT HAS A DUAL LUMEN IVAD THAT REQUIRES DUAL ACCESS. WHEN SHE HAD A SINGLE LUMEN IVAD THEY WERE USING GRIPPER NEEDLES FROM SMITHS MEDICAL (AND HE SAID THAT THIS IS WHAT THE LIHN PROVIDED HIM WITH) AND THEY WORKED GREAT, BUT WHEN SHE WENT TO A DUAL LUMEN, THE GRIPPERS DIDN¿T FIT SIDE BY SIDE. HE STATED THAT THE HOSPITAL INSERTED OUR BARD¿ WIS 20G WITH Y-SITE 0.75" FOR HER DUAL LUMEN ACCESS SO THE CARE PROVIDER ASKED THE LIHN FOR THESE BUT THEY DIDN¿T PROVIDE THEM. SO HE SOURCED OUT A PLACE TO BUY OURS INSTEAD (CARDINAL) S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328238 ↗
• MalfunctionAug 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA CHAT "ALL 5 GRIPPERS THAT I HAVE USED SO FAR LEAKS FROM A CRACK ON THE PLASTIC TUBING. WE RECEIVED A BOX OF GRIPPERS A WEEK AGO AND WE HAVE USED FIVE OF THE SO FAR. I RECEIVE SEVERAL DIFFERENT MEDICATION VIA PUMPS AND SYRINGES (PUSH). AFTER A FEW USES, A CRACK DEVELOPS AND MEDICATION LEAKS OUT. THE CRACK IS LOCATED IN THE CLEAR TUBING BETWEEN THE Y FITTING AND THE NEEDLE. THESE DEVISES WERE PURCHASE AT A LOCAL HOME CARE SERVICE PROVIDER IN CANADA. SO FAR EACH AND EVERY ONE OF THEM HAS FAILED AFTER 1 DAY OF USE.¿ ADD INFO REC'D 08/24/2022: IT WAS REPORTED BY MS&S " CONTACTED CUSTOMER OVER THE PHONE. WE DISCUSSED HIS SITUATION ¿ HE HAS A DAUGHTER THAT HAS A DUAL LUMEN IVAD THAT REQUIRES DUAL ACCESS. WHEN SHE HAD A SINGLE LUMEN IVAD THEY WERE USING GRIPPER NEEDLES FROM SMITHS MEDICAL (AND HE SAID THAT THIS IS WHAT THE LIHN PROVIDED HIM WITH) AND THEY WORKED GREAT, BUT WHEN SHE WENT TO A DUAL LUMEN, THE GRIPPERS DIDN¿T FIT SIDE BY SIDE. HE STATED THAT THE HOSPITAL INSERTED OUR BARD¿ WIS 20G WITH Y-SITE 0.75" FOR HER DUAL LUMEN ACCESS SO THE CARE PROVIDER ASKED THE LIHN FOR THESE BUT THEY DIDN¿T PROVIDE THEM. SO HE SOURCED OUT A PLACE TO BUY OURS INSTEAD (CARDINAL) S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328091 ↗
• MalfunctionAug 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA CHAT "ALL 5 GRIPPERS THAT I HAVE USED SO FAR LEAKS FROM A CRACK ON THE PLASTIC TUBING. WE RECEIVED A BOX OF GRIPPERS A WEEK AGO AND WE HAVE USED FIVE OF THE SO FAR. I RECEIVE SEVERAL DIFFERENT MEDICATION VIA PUMPS AND SYRINGES (PUSH). AFTER A FEW USES, A CRACK DEVELOPS AND MEDICATION LEAKS OUT. THE CRACK IS LOCATED IN THE CLEAR TUBING BETWEEN THE Y FITTING AND THE NEEDLE. THESE DEVISES WERE PURCHASE AT A LOCAL HOME CARE SERVICE PROVIDER IN CANADA. SO FAR EACH AND EVERY ONE OF THEM HAS FAILED AFTER 1 DAY OF USE.¿ ADD INFO REC'D (B)(6) 2022. IT WAS REPORTED BY MS&S " CONTACTED CUSTOMER OVER THE PHONE. WE DISCUSSED HIS SITUATION ¿ HE HAS A DAUGHTER THAT HAS A DUAL LUMEN IVAD THAT REQUIRES DUAL ACCESS. WHEN SHE HAD A SINGLE LUMEN IVAD THEY WERE USING GRIPPER NEEDLES FROM SMITHS MEDICAL (AND HE SAID THAT THIS IS WHAT THE LIHN PROVIDED HIM WITH) AND THEY WORKED GREAT, BUT WHEN SHE WENT TO A DUAL LUMEN, THE GRIPPERS DIDN¿T FIT SIDE BY SIDE. HE STATED THAT THE HOSPITAL INSERTED OUR BARD¿ WIS 20G WITH Y-SITE 0.75" FOR HER DUAL LUMEN ACCESS SO THE CARE PROVIDER ASKED THE LIHN FOR THESE BUT THEY DIDN¿T PROVIDE THEM. SO HE SOURCED OUT A PLACE TO BUY OURS INSTEAD (CARDINAL)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328076 ↗
• MalfunctionAug 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA CHAT "ALL 5 GRIPPERS THAT I HAVE USED SO FAR LEAKS FROM A CRACK ON THE PLASTIC TUBING. WE RECEIVED A BOX OF GRIPPERS A WEEK AGO AND WE HAVE USED FIVE OF THE SO FAR. I RECEIVE SEVERAL DIFFERENT MEDICATION VIA PUMPS AND SYRINGES (PUSH). AFTER A FEW USES, A CRACK DEVELOPS AND MEDICATION LEAKS OUT. THE CRACK IS LOCATED IN THE CLEAR TUBING BETWEEN THE Y FITTING AND THE NEEDLE. THESE DEVISES WERE PURCHASE AT A LOCAL HOME CARE SERVICE PROVIDER IN CANADA. SO FAR EACH AND EVERY ONE OF THEM HAS FAILED AFTER 1 DAY OF USE.¿ ADD INFO REC'D 08/24/2022: IT WAS REPORTED BY MS&S " CONTACTED CUSTOMER OVER THE PHONE. WE DISCUSSED HIS SITUATION ¿ HE HAS A DAUGHTER THAT HAS A DUAL LUMEN IVAD THAT REQUIRES DUAL ACCESS. WHEN SHE HAD A SINGLE LUMEN IVAD THEY WERE USING GRIPPER NEEDLES FROM SMITHS MEDICAL (AND HE SAID THAT THIS IS WHAT THE LIHN PROVIDED HIM WITH) AND THEY WORKED GREAT, BUT WHEN SHE WENT TO A DUAL LUMEN, THE GRIPPERS DIDN¿T FIT SIDE BY SIDE. HE STATED THAT THE HOSPITAL INSERTED OUR BARD¿ WIS 20G WITH Y-SITE 0.75" FOR HER DUAL LUMEN ACCESS SO THE CARE PROVIDER ASKED THE LIHN FOR THESE BUT THEY DIDN¿T PROVIDE THEM. SO HE SOURCED OUT A PLACE TO BUY OURS INSTEAD (CARDINAL) S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328059 ↗
• MalfunctionAug 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA CHAT "ALL 5 GRIPPERS THAT I HAVE USED SO FAR LEAKS FROM A CRACK ON THE PLASTIC TUBING. WE RECEIVED A BOX OF GRIPPERS A WEEK AGO AND WE HAVE USED FIVE OF THE SO FAR. I RECEIVE SEVERAL DIFFERENT MEDICATION VIA PUMPS AND SYRINGES (PUSH). AFTER A FEW USES, A CRACK DEVELOPS AND MEDICATION LEAKS OUT. THE CRACK IS LOCATED IN THE CLEAR TUBING BETWEEN THE Y FITTING AND THE NEEDLE. THESE DEVISES WERE PURCHASE AT A LOCAL HOME CARE SERVICE PROVIDER IN CANADA. SO FAR EACH AND EVERY ONE OF THEM HAS FAILED AFTER 1 DAY OF USE.¿ ADD INFO REC'D 08/24/2022: IT WAS REPORTED BY MS&S " CONTACTED CUSTOMER OVER THE PHONE. WE DISCUSSED HIS SITUATION ¿ HE HAS A DAUGHTER THAT HAS A DUAL LUMEN IVAD THAT REQUIRES DUAL ACCESS. WHEN SHE HAD A SINGLE LUMEN IVAD THEY WERE USING GRIPPER NEEDLES FROM SMITHS MEDICAL (AND HE SAID THAT THIS IS WHAT THE LIHN PROVIDED HIM WITH) AND THEY WORKED GREAT, BUT WHEN SHE WENT TO A DUAL LUMEN, THE GRIPPERS DIDN¿T FIT SIDE BY SIDE. HE STATED THAT THE HOSPITAL INSERTED OUR BARD¿ WIS 20G WITH Y-SITE 0.75" FOR HER DUAL LUMEN ACCESS SO THE CARE PROVIDER ASKED THE LIHN FOR THESE BUT THEY DIDN¿T PROVIDE THEM. SO HE SOURCED OUT A PLACE TO BUY OURS INSTEAD (CARDINAL) S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328023 ↗
• MalfunctionFeb 17, 2022Defective Component; Defective Component

  IT WAS REPORTED THE NEEDLE EXTENSION HAS AN INJECTION PORT WHICH FILLS WITH BLOOD WHEN VENOUS RETURN FROM THE CATHETER PORT IS VERIFIED. HEMATIC RESIDUES IN THE INJECTION PORT SEGMENT CAN LEAD TO BLOODSTREAM INFECTION AND/OR CLOT FORMATION WITH THE RISK OF HUBER NEEDLE OBSTRUCTION. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552269 ↗
• MalfunctionFeb 17, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT WHEN ADMINISTERING BLOOD OR BLOOD PRODUCTS, RESIDUES ACCUMULATE IN THE INJECTION PORT SEGMENT, CONDITIONING THE RISK OF BLOODSTREAM INFECTION AND RISK OF OBSTRUCTION. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552252 ↗
• MalfunctionFeb 17, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT WHEN ADMINISTERING BLOOD OR BLOOD PRODUCTS, RESIDUES ACCUMULATE IN THE INJECTION PORT SEGMENT, CONDITIONING THE RISK OF BLOODSTREAM INFECTION AND RISK OF OBSTRUCTION. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552237 ↗
• MalfunctionFeb 17, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT WHEN ADMINISTERING BLOOD OR BLOOD PRODUCTS, RESIDUES ACCUMULATE IN THE INJECTION PORT SEGMENT, CONDITIONING THE RISK OF BLOODSTREAM INFECTION AND RISK OF OBSTRUCTION. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552234 ↗
• MalfunctionFeb 17, 2022Failure to Infuse; Failure to Infuse

  HOLD FOR AS 02.18. IT WAS REPORTED THAT WHEN ADMINISTERING BLOOD OR BLOOD PRODUCTS, RESIDUES ACCUMULATE IN THE INJECTION PORT SEGMENT, CONDITIONING THE RISK OF BLOODSTREAM INFECTION AND RISK OF OBSTRUCTION. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552222 ↗
• MalfunctionFeb 17, 2022Defective Component; Defective Component

  IT WAS REPORTED THE NEEDLE EXTENSION HAS AN INJECTION PORT WHICH FILLS WITH BLOOD WHEN VENOUS RETURN FROM THE CATHETER PORT IS VERIFIED. HEMATIC RESIDUES IN THE INJECTION PORT SEGMENT CAN LEAD TO BLOODSTREAM INFECTION AND/OR CLOT FORMATION WITH THE RISK OF HUBER NEEDLE OBSTRUCTION. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552160 ↗
• MalfunctionFeb 17, 2022Defective Component; Defective Component

  IT WAS REPORTED THE NEEDLE EXTENSION HAS AN INJECTION PORT WHICH FILLS WITH BLOOD WHEN VENOUS RETURN FROM THE CATHETER PORT IS VERIFIED. HEMATIC RESIDUES IN THE INJECTION PORT SEGMENT CAN LEAD TO BLOODSTREAM INFECTION AND/OR CLOT FORMATION WITH THE RISK OF HUBER NEEDLE OBSTRUCTION. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552151 ↗
• MalfunctionFeb 17, 2022Defective Component; Defective Component

  IT WAS REPORTED THE NEEDLE EXTENSION HAS AN INJECTION PORT WHICH FILLS WITH BLOOD WHEN VENOUS RETURN FROM THE CATHETER PORT IS VERIFIED. HEMATIC RESIDUES IN THE INJECTION PORT SEGMENT CAN LEAD TO BLOODSTREAM INFECTION AND/OR CLOT FORMATION WITH THE RISK OF HUBER NEEDLE OBSTRUCTION. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552144 ↗
• MalfunctionFeb 17, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT TO CONNECT THE SYRINGE OR VENOCLYSIS EQUIPMENT TO THE INJECTION PORT, TO ADMINISTER ANY DRUG INFUSION, IT IS NECESSARY TO REMOVE THE CAP FROM THE INJECTION PORT, WHICH CAN CONDITION THE ENTRY OF AIR TO THE PATIENT, THE ABOVE DERIVED FROM THE SEGMENT BETWEEN THE PORT INJECTION AND ANGLED NEEDLE, IT DOES NOT HAVE A CLAMP OR SAFETY CLIP. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550276 ↗
• MalfunctionFeb 17, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT TO CONNECT THE SYRINGE OR VENOCLYSIS EQUIPMENT TO THE INJECTION PORT, TO ADMINISTER ANY DRUG INFUSION, IT IS NECESSARY TO REMOVE THE CAP FROM THE INJECTION PORT, WHICH CAN CONDITION THE ENTRY OF AIR TO THE PATIENT, THE ABOVE DERIVED FROM THE SEGMENT BETWEEN THE PORT INJECTION AND ANGLED NEEDLE, IT DOES NOT HAVE A CLAMP OR SAFETY CLIP. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550269 ↗
• MalfunctionFeb 17, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT TO CONNECT THE SYRINGE OR VENOCLYSIS EQUIPMENT TO THE INJECTION PORT, TO ADMINISTER ANY DRUG INFUSION, IT IS NECESSARY TO REMOVE THE CAP FROM THE INJECTION PORT, WHICH CAN CONDITION THE ENTRY OF AIR TO THE PATIENT, THE ABOVE DERIVED FROM THE SEGMENT BETWEEN THE PORT INJECTION AND ANGLED NEEDLE, IT DOES NOT HAVE A CLAMP OR SAFETY CLIP. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550268 ↗
• MalfunctionFeb 17, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT TO CONNECT THE SYRINGE OR VENOCLYSIS EQUIPMENT TO THE INJECTION PORT, TO ADMINISTER ANY DRUG INFUSION, IT IS NECESSARY TO REMOVE THE CAP FROM THE INJECTION PORT, WHICH CAN CONDITION THE ENTRY OF AIR TO THE PATIENT, THE ABOVE DERIVED FROM THE SEGMENT BETWEEN THE PORT INJECTION AND ANGLED NEEDLE, IT DOES NOT HAVE A CLAMP OR SAFETY CLIP. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550266 ↗
• MalfunctionDec 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PRODUCT COMPLAINT REGARDING THE PORT NEEDLES. A PATIENT WAS HAVING HIS MEDICATION THROUGH HIS PORT WITH PORT NEEDLE. ACCORDING TO THE NURSE THE CAP ON THE NEEDLE, WAS LOOSE ON WHEN THE NEEDLE WAS PLACED. THIS TIME THEY DID NOT NOTICE IT WAS LOOSE. THE PATIENT WAS GETTING HIS CANCER TREATMENT, FELL ASLEEP AND THE MEDICATION DRIPPED OUT OF THE CAP AND ALL OVER THE PATIENT AND HIS BED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079760 ↗
• MalfunctionDec 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT FOLLOWING ACCESSING OF A PORT A CATH WITHOUT INCIDENT, FLUSHING USING 10ML SYRINGE AND SECURING IN PLACE WITH IV 3000, THE INJECTABLE SIDE PORT CAME OFF OF THE ACCESS NEEDLE CAUSING A FREE FLOW OF BLOOD, PRIOR TO ACCESSING PORT A CATH NO APPARENT FAULTS NOTED WITH THE ACCESS NEEDLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12924837 ↗
• MalfunctionOct 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WINGED INFUSION SET WITH INJECTION SITE FOUND THAT LEAKING IV FLUID. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586485 ↗
• MalfunctionOct 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WINGED INFUSION SET WITH INJECTION SITE FOUND THAT LEAKING IV FLUID. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586483 ↗
• MalfunctionOct 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WINGED INFUSION SET WITH INJECTION SITE FOUND THAT LEAKING IV FLUID. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586468 ↗
• MalfunctionSep 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAK ON THE TUBING OF NEEDLE G 20. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12529763 ↗