INTERA AP-07014USRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00850014110079), received between Nov 22, 2022 and May 4, 2026 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (29 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Fluid/Blood Leak

  A CLINIC INFORMED INTERA ONCOLOGY THAT DURING A REFILL PROCEDURE ON (B)(6) 2026, THEY EXPERIENCED A LEAK FROM THE REFILL KIT. ACCORDING TO THE CLINIC THE NEEDLE WAS SCREWED ON TIGHTLY TO THE TUBING, BUT WHEN FLOXURIDINE WAS PUSHED THROUGH THE TUBING, IT LEAKED FROM THE LUERLOCK BETWEEN THE TUBING AND NEEDLE. THE PATIENT'S SKIN WAS EXPOSED TO FLOXURIDINE. HOWEVER, THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION (EX. SKIN IRRITATION, RASH, ETC). IN ADDITION, THE CLINIC DISCARDED THE SAMPLE, AND NO PICTURE OF THE LEAK WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070107 ↗
• MalfunctionApr 30, 2026Break; Fluid/Blood Leak

  INTERA ONCOLOGY WAS NOTIFIED THAT ON (B)(6) 2026, THAT THE REFILL KIT TUBING CRACKED ON DURING A REFILL AND HAD TO RE-ACCESS THE PATIENT'S PUMP. ACCORDING TO THE CLINIC, THE NURSES ARE AWARE OF THIS AND EXERCISE CAUTION WHEN CONNECTING SYRINGE TO THE TUBING. IN ADDITION, THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047058 ↗
• MalfunctionApr 30, 2026Break; Fluid/Blood Leak

  INTERA ONCOLOGY WAS NOTIFIED THAT ON (B)(6) 2026, DURING A REFILL PROCEDURE, THE CLINIC HAD AN INCIDENT WHERE THE REFILL KIT TUBING CRACKED. THE CRACK WAS NOTICED WHEN THEY WENT TO CONNECT THE SYRINGE. THE NURSE WENT TO PUSH THE DRUG AND 1.5CCS LEAKED OUT AT THE CONNECTION SITE BETWEEN THAT SYRINGE AND THE TUBING. THIS SYRINGE WAS THEN DISCONNECTED, AND THEY TESTED THE BACKUP 10CC SALINE SYRINGE THAT WAS PREPARED BY PHARMACY. THIS ALSO LEAKED AT THE SAME SPOT, SO THE NEEDLE WAS DE-ACCESSED. A NEW KIT WAS OBTAINED, AND THE PUMP WAS RE-ACCESSED AND REFILLED FOLLOWING PROCEDURE. ACCORDING TO THE CLINIC, THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046994 ↗
• MalfunctionMar 6, 2026Break; Fluid/Blood Leak

  INTERA ONCOLOGY WAS NOTIFIED THAT A NURSE NOTED FLOXURIDINE LEAKED ON A PATIENT DURING A REFILL PROCEDURE. THE NURSE NOTICED LEAKING FLOXURIDINE WHEN ATTEMPTING TO FLUSH THE LINE FROM EITHER A HOLE IN THE TUBING OR WHERE THE STOPCOCK CONNECTS TO THE PATIENT BELOW THEIR CLOSED SYSTEM TRANSFER DEVICE. INTERA WAS TOLD THAT IT WAS NOT LEAKING PRIOR TO PLACING THE STOPCOCK ON. THE PATIENT'S ABDOMEN WAS CLEANED WITH SOAP AND WATER, AND THERE WAS NO REPORT OF ERYTHEMA, PRURITUS, OR BURNING OF THE SKIN. THE PATIENT AND NURSE WERE NOT WEARING N95'S OR RESPIRATORS BUT NEITHER EXPERIENCED SHORTNESS OF BREATH, WHEEZING, OR BURNING OF THE MOUTH OR NOSE. THE TUBING, SYRINGE, AND ALL REFILL MATERIALS WERE THROWN AWAY DURING THE DECONTAMINATION OF THE ROOM; HOWEVER, THERE WERE TWO PICTURES TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533088 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  INTERA ONCOLOGY WAS NOTIFIED BY A NURSE THAT A REFILL KIT LEAKED FLOXURIDINE (FUDR). THE CLINIC SAVED THE TUBING AND PROVIDED US WITH PHOTOS OF THE PRODUCT LABELING. THE NURSE CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTION. FUDR DID NOT LEAK ONTO THE PATIENT. ACCORDING TO THE NURSE, THE LEAK HAPPENED WHERE THE TUBE CONNECTS TO THE HUB. THE DEVICE HAS NOT BEEN SHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375478 ↗
• MalfunctionDec 30, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  INTERA ONCOLOGY WAS NOTIFIED BY A PHYSICIAN ASSISTANT THAT ON (B)(6) 2025, THAT THEY NOTICED THAT THE END THAT'S CONNECTED TO THE TUBING SET WAS CRACKED WHICH CAUSED FLOXURIDINE (FUDR) TO LEAK DURING THE REFILL PROCEDURE. UPON THE LEAK, THEY ABORTED THE REFILL PROCEDURE, REMOVE THE NEEDLE FROM THE PUMP AND OPENED UP A NEW REFILL KIT AND SUCCESSFULLY REFILLED THE PUMP WITHOUT ANY ISSUES. DURING FOLLOW-UP COMMUNICATION WITH THE CLINIC, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCED AN ADVERSE REACTION AND ONLY EXPERIENCED DELAY IN TREATMENT. THE SAMPLE WAS DISCARDED DUE TO FUDR BEING IN THE LINE. THEY DON'T KNOW HOW THE TUBING BROKE. THE EXACT LOCATION OF THE BREAK WAS WHERE THE PVC TUBING IS ATTACHED TO THE HUB AT THE END. THE CLINIC ONLY PROVIDED US WITH PHOTOS THAT SHOWS THE PACKAGING OF THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923248 ↗
• MalfunctionNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  INTERA ONCOLOGY WAS NOTIFIED BY AN ASSISTANT NURSE MANAGER THAT A REFILL KIT SYRINGE BARREL LEAKED HEPARIN THROUGH THE TYVEK LID DURING A REFILL PROCEDURE ON (B)(6) 2025. THE DEVICE WAS DISCARDED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23562820 ↗
• MalfunctionOct 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A CLINIC REPORTED TO INTERA ONCOLOGY OF HAVING ISSUES WITH THE SYRINGE BARREL LEAKING THROUGH THE TYVEK LID. IN ONE INSTANCE, THE SYRINGE BARREL LEAKED CHEMO ONTO THE PATIENT AND BED DURING A ROUTINE REFILL. DURING COMMUNICATION WITH THE CLINIC, IT WAS MENTIONED THAT THIS HAS BEEN A RECURRING ISSUE. THE DEVICE WAS DISCARDED, AND NO PHOTO OR VIDEO EVIDENCE OF THE LEAK IS AVAILABLE. THE CLINIC MENTIONED THEY LEFT THE SYRINGE BARREL INVERTED ON THE TABLE. IN ADDITION, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214396 ↗
• MalfunctionAug 14, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ON (B)(6) 2025, A NURSE ATTEMPTED TO FILL THE INTERA 3000 HAI PUMP WITH HEPARIN USING THE INTERA 3000 REFILL KIT. THE NURSE NOTICED A CRACK AND LEAKAGE IN THE TUBING NEAREST TO THE SYRINGE. WHEN ASKED WHERE SPECIFICALLY THE CRACK AND LEAKAGE OCCURRED, THE NURSE MENTIONED THAT IT WAS IN THE LUER LOCK CONNECTOR AREA. THE NURSE REPLACED THE TUBING BY USING ANOTHER KIT. NO HARM TO THE PATIENT WAS REPORTED. THE CLINIC DISCARDED THE SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803139 ↗
• MalfunctionJun 5, 2025Material Twisted/Bent; Material Twisted/Bent

  INTERA ONCOLOGY RECEIVED A REPORT FROM A NURSE AT (B)(6) THAT A NEEDLE WAS BENT WHILE ACCESSING A PATIENT'S HAI PUMP. THE FACILITY WAS ABLE TO ACCESS THE PUMP WITH THE OTHER NEEDLE IN THE REFILL KIT AND THE REFILL WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148592 ↗
• MalfunctionApr 22, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  INTERA ONCOLOGY RECEIVED A REPORT OF A TUBING LEAK DURING REFILL PROCEDURE. THE CLINIC MENTIONED THAT THEY NOTICED A CRACK AT THE CONNECTION SITE OF THE SYRINGE. THE CLINIC DISPOSED THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881493 ↗
• MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  INTERA ONCOLOGY RECIEVED A REPORT THAT DURING A REFILL PROCEDURE ON (B)(6) 2024 THE REFILL KIT WAS LEAKING. THE NURSE STATED WHEN ACCESSING THE PORT, THE CHEMO WAS LEAKING OUT FROM THE POINT OF CONTACT BETWEEN THE NEEDLE AND SYRINGE. HER TEAM DECIDED TO REMOVE THE NEEDLE AND SYRINGE AND OPEN A NEW KIT AND WAS SUCCESSFUL IN ACCESSING THE PORT THE SECOND TIME WITHOUT ANY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685266 ↗
• MalfunctionAug 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT THEY HAD 'AN ONGOING ISSUE WITH LEAKING BETWEEN THE INTERA NEEDLE AND CONNECTOR SET.' HEALTHCARE PROVIDER STATED 'THE CONNECTIONS BEING VERY THOROUGHLY TIGHTENED, LEAKING PERSISTS WHEN MEDICATION IS INSTILLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951047 ↗
• MalfunctionJul 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT THEY HAD 'AN ONGOING ISSUE WITH LEAKING BETWEEN THE INTERA NEEDLE AND CONNECTOR SET.' HEALTHCARE PROVIDER STATED 'THE CONNECTIONS BEING VERY THOROUGHLY TIGHTENED, LEAKING PERSISTS WHEN MEDICATION IS INSTILLED. HEALTHCARE PROVIDER ASKED IF THE FEMALE END [OF THE NEEDLE] IS NOT CIRCULAR BUT STRAIGHT ON EITHER SIDE IF THIS COULD BE RESULTING IN A CONNECTION THAT'S NOT SECURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757764 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT WHILE A HEALTHCARE PROVIDER WAS ACCESSING AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP IN A PATIENT, THE TUBING OF AN INTERA REFILL KIT INFUSION SET WAS CRACKED AT THE TOP CONNECTION POINT. THE NURSE WAS ABLE TO SUCCESSFULLY REMOVE THE FUDR, COMPLETE THE 5CC NS CONFIRMATION OF PLACEMENT AND THEN ASKED ANOTHER NURSE TO ASSIST IN CHANGING THE TUBING WITHOUT HAVING TO DE-ACCESS AND RE-ACCESS THE NEEDLE. THIS KIT WAS DISPOSED AS HAZARDOUS WASTE (FUDR).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461075 ↗
• MalfunctionApr 11, 2024Break; Break

  A REPORT WAS RECEIVED BY A HEALTHCARE PROVIDER TO INTERA THAT DURING A REFILL OF THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP USING AN INTERA REFILL KIT, THE 22 GAUGE HUBER NEEDLE BROKE OFF AT THE HUB OF THE NEEDLE WHEN ACCESSING A PATIENT. THE CONTENTS OF THE PUMP RETURNED FROM THE PUMP SO THE PROVIDER KNEW THAT THEY HAD ACCESSED THE PUMP. THE PROVIDER WAS ABLE TO REMOVE THE NEEDLE FROM THE PUMP AND PATIENT. THEY WERE ABLE TO REACCESS WITH THE SECOND NEEDLE IN THE KIT AND COMPLETE THE REFILL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089252 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT THEY EXPERIENCED 2 LEAKS IN INTERA REFILL KIT. ONE WAS REPORTED TO LEAKED AT THE CONNECTION OF THE SYRINGE (DISTAL TO THE NEEDLE) DURING AN NS FLUSH (LOT NUMBER WAS REPORTED TO BE UNKNOWN). ONE LEAKED TODAY AT THE HUBER NEEDLE/TUBING CONNECTION (LOT NUMBER REPORTED TO BE 23K000CT). EXACT DATES OF INCIDENTS WERE NOT REPORTED. IT WAS REPORTED THAT THEY HEALTHCARE PROVIDER THOUGHT THE TUBING APPEARED TO BE TIGHT, "THOUGH ON THE FIRST EVENT, WE DID NOTE THERE WAS A SMALL EXTRA RIDGE OF PLASTIC ON THE TUBING LUER." IT WAS LATER REPORTED BY THE SAME HEALTHCARE PROVIDER THAT THERE WERE 3 TOTAL LEAKS OF LOT #23K000CT WITH THE FOLLOWING DETAILS (1) LEAK AT HUBER NEEDLE TUBING CONNECTION. "A 50 ML SYRINGE WAS CONNECTED. NEEDLE WAS CHECKED BEFORE ACCESS TO ENSURE TIGHT. ON REMOVAL OF NEEDLE, STILL SEEMED TO BE A TIGHT CONNECTION. THEY CHANGED TO NEW REFILL SET [LOT NUMBER NOT NOTED], NO FURTHER LEAKING NOTED." (2) LEAK AT HUBER NEEDLE TUBING CONNECTION. "UNKNOWN WHAT SIZE SYRINGE WAS USED- MAY HAVE BEEN 50CC. RECHECKED CONNECTION, APPEARED BE TIGHT, BUT THEY TIGHTENED AGAIN TO BE SURE. NEEDLE WAS NOT REMOVED, BUT CONTINUED REFILL AND NO FURTHER LE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047990 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT THEY EXPERIENCED 2 LEAKS IN INTERA REFILL KIT. ONE WAS REPORTED TO LEAKED AT THE CONNECTION OF THE SYRINGE (DISTAL TO THE NEEDLE) DURING AN NS FLUSH (LOT NUMBER WAS REPORTED TO BE UNKNOWN). ONE LEAKED TODAY AT THE HUBER NEEDLE/TUBING CONNECTION (LOT NUMBER REPORTED TO BE 23K000CT). EXACT DATES OF INCIDENTS WERE NOT REPORTED. IT WAS REPORTED THAT THEY HEALTHCARE PROVIDER THOUGHT THE TUBING APPEARED TO BE TIGHT, "THOUGH ON THE FIRST EVENT, WE DID NOTE THERE WAS A SMALL EXTRA RIDGE OF PLASTIC ON THE TUBING LUER." IT WAS LATER REPORTED BY THE SAME HEALTHCARE PROVIDER THAT THERE WERE 3 TOTAL LEAKS OF LOT #23K000CT WITH THE FOLLOWING DETAILS (1) LEAK AT HUBER NEEDLE TUBING CONNECTION. "A 50 ML SYRINGE WAS CONNECTED. NEEDLE WAS CHECKED BEFORE ACCESS TO ENSURE TIGHT. ON REMOVAL OF NEEDLE, STILL SEEMED TO BE A TIGHT CONNECTION. THEY CHANGED TO NEW REFILL SET [LOT NUMBER NOT NOTED], NO FURTHER LEAKING NOTED." (2) LEAK AT HUBER NEEDLE TUBING CONNECTION. "UNKNOWN WHAT SIZE SYRINGE WAS USED- MAY HAVE BEEN 50CC. RECHECKED CONNECTION, APPEARED BE TIGHT, BUT THEY TIGHTENED AGAIN TO BE SURE. NEEDLE WAS NOT REMOVED, BUT CONTINUED REFILL AND NO FURTHER LE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047969 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT THEY EXPERIENCED 2 LEAKS IN INTERA REFILL KIT. ONE WAS REPORTED TO LEAKED AT THE CONNECTION OF THE SYRINGE (DISTAL TO THE NEEDLE) DURING AN NS FLUSH (LOT NUMBER WAS REPORTED TO BE UNKNOWN). ONE LEAKED TODAY AT THE HUBER NEEDLE/TUBING CONNECTION (LOT NUMBER REPORTED TO BE 23K000CT). EXACT DATES OF INCIDENTS WERE NOT REPORTED. IT WAS REPORTED THAT THEY HEALTHCARE PROVIDER THOUGHT THE TUBING APPEARED TO BE TIGHT, "THOUGH ON THE FIRST EVENT, WE DID NOTE THERE WAS A SMALL EXTRA RIDGE OF PLASTIC ON THE TUBING LUER." IT WAS LATER REPORTED BY THE SAME HEALTHCARE PROVIDER THAT THERE WERE 3 TOTAL LEAKS OF LOT #23K000CT WITH THE FOLLOWING DETAILS (1) LEAK AT HUBER NEEDLE TUBING CONNECTION. "A 50 ML SYRINGE WAS CONNECTED. NEEDLE WAS CHECKED BEFORE ACCESS TO ENSURE TIGHT. ON REMOVAL OF NEEDLE, STILL SEEMED TO BE A TIGHT CONNECTION. THEY CHANGED TO NEW REFILL SET [LOT NUMBER NOT NOTED], NO FURTHER LEAKING NOTED." (2) LEAK AT HUBER NEEDLE TUBING CONNECTION. "UNKNOWN WHAT SIZE SYRINGE WAS USED- MAY HAVE BEEN 50CC. RECHECKED CONNECTION, APPEARED BE TIGHT, BUT THEY TIGHTENED AGAIN TO BE SURE. NEEDLE WAS NOT REMOVED, BUT CONTINUED REFILL AND NO FURTHER LE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047967 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT THEY EXPERIENCED 2 LEAKS IN INTERA REFILL KIT. ONE WAS REPORTED TO LEAKED AT THE CONNECTION OF THE SYRINGE (DISTAL TO THE NEEDLE) DURING AN NS FLUSH (LOT NUMBER WAS REPORTED TO BE UNKNOWN). ONE LEAKED TODAY AT THE HUBER NEEDLE/TUBING CONNECTION (LOT NUMBER REPORTED TO BE 23K000CT). EXACT DATES OF INCIDENTS WERE NOT REPORTED. IT WAS REPORTED THAT THEY HEALTHCARE PROVIDER THOUGHT THE TUBING APPEARED TO BE TIGHT, "THOUGH ON THE FIRST EVENT, WE DID NOTE THERE WAS A SMALL EXTRA RIDGE OF PLASTIC ON THE TUBING LUER." IT WAS LATER REPORTED BY THE SAME HEALTHCARE PROVIDER THAT THERE WERE 3 TOTAL LEAKS OF LOT #23K000CT WITH THE FOLLOWING DETAILS (1) LEAK AT HUBER NEEDLE TUBING CONNECTION. "A 50 ML SYRINGE WAS CONNECTED. NEEDLE WAS CHECKED BEFORE ACCESS TO ENSURE TIGHT. ON REMOVAL OF NEEDLE, STILL SEEMED TO BE A TIGHT CONNECTION. THEY CHANGED TO NEW REFILL SET [LOT NUMBER NOT NOTED], NO FURTHER LEAKING NOTED." (2) LEAK AT HUBER NEEDLE TUBING CONNECTION. "UNKNOWN WHAT SIZE SYRINGE WAS USED- MAY HAVE BEEN 50CC. RECHECKED CONNECTION, APPEARED BE TIGHT, BUT THEY TIGHTENED AGAIN TO BE SURE. NEEDLE WAS NOT REMOVED, BUT CONTINUED REFILL AND NO FURTHER LE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047964 ↗
• MalfunctionApr 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT THEY EXPERIENCED 2 LEAKS IN INTERA REFILL KIT. ONE WAS REPORTED TO LEAKED AT THE CONNECTION OF THE SYRINGE (DISTAL TO THE NEEDLE) DURING AN NS FLUSH (LOT NUMBER WAS REPORTED TO BE UNKNOWN). ONE LEAKED TODAY AT THE HUBER NEEDLE/TUBING CONNECTION (LOT NUMBER REPORTED TO BE 23K000CT). EXACT DATES OF INCIDENTS WERE NOT REPORTED. IT WAS REPORTED THAT THEY HEALTHCARE PROVIDER THOUGHT THE TUBING APPEARED TO BE TIGHT, "THOUGH ON THE FIRST EVENT, WE DID NOTE THERE WAS A SMALL EXTRA RIDGE OF PLASTIC ON THE TUBING LUER." IT WAS LATER REPORTED BY THE SAME HEALTHCARE PROVIDER THAT THERE WERE 3 TOTAL LEAKS OF LOT #23K000CT WITH THE FOLLOWING DETAILS (1) LEAK AT HUBER NEEDLE TUBING CONNECTION. "A 50 ML SYRINGE WAS CONNECTED. NEEDLE WAS CHECKED BEFORE ACCESS TO ENSURE TIGHT. ON REMOVAL OF NEEDLE, STILL SEEMED TO BE A TIGHT CONNECTION. THEY CHANGED TO NEW REFILL SET [LOT NUMBER NOT NOTED], NO FURTHER LEAKING NOTED." (2) LEAK AT HUBER NEEDLE TUBING CONNECTION. "UNKNOWN WHAT SIZE SYRINGE WAS USED- MAY HAVE BEEN 50CC. RECHECKED CONNECTION, APPEARED BE TIGHT, BUT THEY TIGHTENED AGAIN TO BE SURE. NEEDLE WAS NOT REMOVED, BUT CONTINUED REFILL AND NO FURTHER LE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047962 ↗
• MalfunctionMar 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT INTERA REFILL KIT WAS LEAKING. INTERA REQUESTED THAT THE KIT BE RETURNED FOR EVALUATION, BUT THE HEALTHCARE PROVIDER REPORTED THAT IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992731 ↗
• MalfunctionMar 22, 2024Leak/Splash; Leak/Splash

  A REPORT WAS RECEIVED BY A HEALTHCARE PROVIDER REGARDING USE OF THE INTERA REFILL KIT THE HEALTHCARE PROVIDERE STATED THEY HAD 'ISSUES WITH TWO TUBINGS FROM THE INTERA HAI PUMP REFILL KITS. THE TUBING LEAKED FROM WHERE IT CONNECTS TO THE NEEDLE FROM BOTH KITS. THE KITS HAVE THE SAME LOT NUMBER OF 23J038CT. WE ATTEMPTED A THIRD KIT WHICH HAD A DIFFERENT LOT NUMBER, AND THE TUBING DID NOT LEAK SO WE COULD SUCCESSFULLY FILL THE PT'S PUMP".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18964695 ↗
• MalfunctionMar 22, 2024Leak/Splash; Leak/Splash

  A REPORT WAS RECEIVED BY A HEALTHCARE PROVIDER REGARDING USE OF THE INTERA REFILL KIT THE HEALTHCARE PROVIDERE STATED THEY HAD 'ISSUES WITH TWO TUBINGS FROM THE INTERA HAI PUMP REFILL KITS. THE TUBING LEAKED FROM WHERE IT CONNECTS TO THE NEEDLE FROM BOTH KITS. THE KITS HAVE THE SAME LOT NUMBER OF 23J038CT. WE ATTEMPTED A THIRD KIT WHICH HAD A DIFFERENT LOT NUMBER, AND THE TUBING DID NOT LEAK SO WE COULD SUCCESSFULLY FILL THE PT'S PUMP"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18964635 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT A HEALTHCARE PROVIDER WAS ACCESSING AN [IMPLANTED INFUSION] PUMP, SHE NOTICED THAT GLYCERIN WAS RETURNING TO THE SYRINGE BARREL AND ALSO TO BE LEAKING AT THE END OF THE TUBING. SHE CLAMPED THE TUBING, ADJUSTED AND TIGHTENED THE CONNECTIONS, AND THEN TRIED AGAIN. ONCE THE TUBING WAS UNCLAMPED, GLYCERIN WAS STILL NOTED TO BE LEAKING. UPON FURTHER INSPECTION, SHE NOTICED THE TUBING WAS CRACKED (PICTURE BELOW) AND THE GLYCERIN WAS LEAKING FROM THE CRACKED TUBING. THE NURSE DISCONNECTED THE TUBING AND DE-ACCESSED THE PUMP. SHE THEN RE-ACCESSED WITH A NEW KIT AND CONTINUED TO EMPTY THE PUMP. SHE WAS ABLE TO REFILL THE PUMP WITH NEW MEDICATION WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843152 ↗