Port Access Needle 0671910Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741047893), received between Oct 16, 2019 and Aug 15, 2024 — classified as 1 injury, 16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT RECENTLY HAD AN INCIDENT WITH A PATIENT¿S PORT TUBING COMING APART (SEVERED) OR CRACK COMPLETELY OFF WHILE HOME-CHEMO 5FU WAS BEING INFUSED. THE PORT NEEDLE REMAINED INTACT BUT THE TUBING WAS COMPLETELY SEVERED OFF IN THE DRESSING ALLOWING FOR LEAKAGE OF CHEMO, BLEEDING FROM THE TUBING, UNABLE TO CLAMP THE PORT NEEDLE DUE TO THE DISCONNECTION OF THE TUBING WITH THE CLAMP WAS NO LONGER CONNECTED OR INTACT WITH AN OPPORTUNITY FOR AN INFECTION TO ENTER. PATIENT PRESENTING TO TREATMENT AREA WITH 5FU CADD PUMP CONNECTED FOR IVF AND REPEAT LAB WORK. PER PATIENT, PORT TUBING HAD COME "DISCONNECTED" AT HOME OVERNIGHT WHILE 5FU INFUSING AND SHE REPORTS HAVING "RECONNECTED" TUBING AFTER WAKING UP AND SEEING BLOOD ON HER BED SHEETS FROM PORT TUBING. NO RESIDUAL 5FU NOTED ON PATIENT'S SKIN. CADD PUMP STOPPED AND UPON INSPECTION OF PORT, PORT TUBING HAD SEVERED ABOVE PROXIMAL LUMEN. PATIENT DISCONNECTED FROM CADD PUMP AND PORT DEACCESSED. UPON DISCUSSION W/ APP, CADD PUMP NOT TO BE RECONNECTED AND OKAY TO REACCESS PORT FOR IVF AND LABWORK. NO FURTHER INTERVENTIONS NEEDED REGARDING SEVERED TUBING PER APP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19991576 ↗
• InjuryMay 20, 2024Activation Problem; Activation Problem

  IT WAS REPORTED NURSE SAID THAT THE POWERLOC SAFETY DID NOT ENGAGE AND RESULTING IN GETTING STUCK IN THE FINGER. NEEDLESTICK OCCURRED AFTER PORT WAS DE-ACCESSED AND TREATMENT WAS FINISHED, AND DID NOT CAUSE ANY URGENT MEDICAL SITUATIONS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19354943 ↗
• MalfunctionDec 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "I HAVE A PORT NEEDLE WITH Y-SITE THAT LEAKED AT THE CONNECTOR Y-SITE. THIS AREA HAS NOTABLE WHITE POWDER ON THE TUBING AND CONNECTOR AND IS NOT SITE WHERE THE CHARTWELL PUMP TUBING WAS CONNECTED TO." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18412788 ↗
• MalfunctionDec 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT NO PATIENT HARM, BUT PATIENT WAS EXPOSED TO CHEMO LEAK AND WAS IN PUBLIC WHEN THE LEAK OCCURRED. THE CONNECTOR CAME OFF OF THE TUBING EXPOSING THE LUMEN. PATIENT CALLED, ADVISED TO TURN OFF AND COME IN TO BE EVALUATED THE SAME DAY. A NEW CASSETTE WAS GIVEN THE NEXT DAY TO PATIENT TO RECEIVE MEDICATION. IT WAS STATED THERE WAS A DELAY IN CARE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Chemical Exposure

  MAUDE report 18285617 ↗
• MalfunctionDec 7, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PATIENT HAD BEEN DISCHARGED WITH THE NEEDLE/CAP INTACT. LEAK FOUND UPON PUMP DC" THIS WAS A PATIENT WHO WAS DISCHARGED TO HOME FOR IV MEDICATION AND RETURNED TO THE CENTER AS DESCRIBED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283813 ↗
• MalfunctionOct 26, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT "WE HAVE A LEAK FROM OUR PORT NEEDLE. THE PATIENT CAME TO HAVE PUMP DISCONNECTED TODAY ON 10-9-23. PRIOR TO DISCONNECTING THE NURSE NOTICED A MODERATE AMOUNT OF WHITE POWDER AND LEAKAGE FROM THE END OF THE TUBING SITE AWAY FROM THE NEEDLE AREA WHERE THE MICRO-CLAVE CAP AND TUBING CONNECTS. PATIENT RECEIVED MEDICATION BUT WITH THE WHITE POWDER, PATIENT CAN BE EXPOSED TO CHEMO LEAKAGE TO SKIN."

  Patient problems: Chemical Exposure

  MAUDE report 18016900 ↗
• MalfunctionOct 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY DISCONNECT, AND NURSE NOTICED LARGE AMOUNT OF WHITE POWDER IN THE MAIN LINE TUBING END OF THE PORT WHERE THE CAP CONNECTS TO THE TUBING. THE CONNECTOR CAP IS MICRO CLAVE CLEARA NEUTRAL CONNECTOR BY ICU MEDICAL. PORT INFUSION SET, PATIENT RECEIVED ENTIRE 5 FU , CAME INTO CLINIC ON (B)(6) 2023 FOR DISCONNECT AND NURSE NOTICED LARGE AMOUNT OF WHITE POWDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906919 ↗
• MalfunctionOct 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT ARRIVED TO PORT LAB FOR 5FU PUMP DISCONNECT. WHITE POWDER WAS NOTED TO BE ON PATIENTS LEFT UPPER CHEST AND AROUND THE THREADING OF THE DISTAL LUMEN OF THE PORT NEEDLE. PATIENT WAS FLUSHED, HEPARINIZED, AND DEACCESSED. PATIENT'S CHEST WAS CLEANSED WITH SOAP AND WATER. DISCHARGED AMBULATORY IN STABLE CONDITION. EXACT LOCATION OF THE LEAK: DISTAL LUMEN. CONNECTOR TYPE: MICROCLAVE. TREATMENT REGIMEN: FOLFIRI DRUG RECEIVED DURING LEAK. 5FU PUMP DISCONNECTED AT 46 HOURS AFTER INFUSION BEGAN AT 2:30PM. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023: INVOLVED THE PATIENT DUE TO THE LEAK. TREATMENT WAS COMPLETED. EXPOSURE OF CHEMO TO SKIN BUT NO HARM. LEAKAGE OCCURRED FROM THE PORT TUBING END POINT.

  Patient problems: Chemical Exposure

  MAUDE report 17873698 ↗
• MalfunctionOct 4, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT RECEIVED FOLFOX/MVASI. DRY 5FU FROM HIS 48 INFUSION, NOTED ON THREADS BETWEEN PORT NEEDLE AND MICROCLAVE CAP OF BOTH LUMENS. PATIENT DIDN'T RELATE ANY NOTICE ON SKIN OR CLOTHING. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 10/12/2023: INVOLVED PATIENT, TREATMENT WAS COMPLETED. EXPOSURE OF CHEMO TO SKIN BUT NO HARM. LEAKAGE OCCURRED FROM THE PORT TUBING END POINT.

  Patient problems: Chemical Exposure

  MAUDE report 17872894 ↗
• MalfunctionOct 4, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PATIENT PRESENTED FOR AMBULATORY FLUOROURACIL PUMP DISCONNECT. PATIENT RECEIVES FOLFIRI + CETUXIMAB. PATIENT HAD VISIBLE DRUG LEAKING (WHITE POWDER) AROUND UPPER LUMEN CAP. MICROCLAVE LUER LOCK CONNECTOR. NO VISIBLE DRUG ON PATIENT'S CLOTHING OR SKIN. PATIENT ACCESSED ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 26 SEP 2023: IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT. PATIENT RECEIVED MEDICATION BUT COULD HAVE BEEN EXPOSED TO THE CHEMO AGENT IN RESULTS OF THE NOTABLE WHITE POWDER.

  Patient problems: Chemical Exposure

  MAUDE report 17872892 ↗
• MalfunctionAug 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CUSTOMER HAD A LEAK OVER THE WEEKEND. THE AREA OF LEAK IS AT THE PORT TUBING AND NOT THE TUBING TO THE CASSETTE, THIS IS ALSO EXPOSING PATIENT¿S SKIN TO THE CHEMOTHERAPY. ADD INFO RECEIVED ON 21-AUG-2023. PATIENT DID NOT RECEIVE ALL OF PRESCRIBED CHEMO. LEAK DISCOVERED BY PATIENT. YES, THERE IS INTERRUPTION OF ADMINISTRATION OF MEDICATION/CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION THAT NEGATIVELY IMPACTED THE PATIENT. PATIENT DID NOT RECEIVE ALL PRESCRIBED CHEMO FOR CANCER REGIMEN, PATIENT WAS EXPOSED TO THE CHEMO. CHEMO EXPOSURE, NO HARM.

  Patient problems: Chemical Exposure

  MAUDE report 17638863 ↗
• MalfunctionAug 25, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK, AROUND THE Y-SITE END AREA OF THE PORT TUBING. PATIENT RECEIVING IMMUNOTHERAPY AND COMPLETED IT, STAFF NOTICED LEAKAGE AT THE SITE PRIOR TO CONNECTING TO PUMP. CHANGED THE ENTIRE PORT NEEDLE AND NO FURTHER LEAKAGE NOTED. RECEIVED MEDICATION FROM PUMP. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION RECEIVED 8/21/2023: IT WAS REPORTED THERE IS INTERRUPTION OF ADMINISTRATION OF MEDICATION/CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION THAT NEGATIVELY IMPACTED THE PATIENT. PATIENT DID NOT RECEIVE ALL PRESCRIBED CHEMO FOR CANCER REGIMEN, PATIENT WAS EXPOSED TO THE CHEMO. CHEMO EXPOSURE, NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17626975 ↗
• MalfunctionSep 7, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED "THEY WERE ABLE TO FLUSH BEFORE ACCESSING BUT ONCE ACCESSED NEEDLE WAS NOT FLUSHING OR ASPIRATING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375226 ↗
• MalfunctionFeb 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH ¿PORT NEEDLE DISCOVERED LEAKING FROM A SMALL HOLE RESULTING IN A CHEMO SPILL.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514769 ↗
• MalfunctionAug 20, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED VIA MS&S "NURSE ASKING ABOUT DRAWING BLOOD USING POWERLOC NEEDLE WITH PORTS AS SHE IS HEARING REPORTS OF NUMEROUS HEMOLYZED BLOOD SAMPLES RECENTLY. NURSE HAS SOME CONCERN THAT TECHNICIANS DRAWING BLOOD MAY NOT HAVE PROPER TRAINING." MS&S RESPONSE: "REVIEWED BLOOD SAMPLING PROCEDURE SECTION OF POWERPORT NURSING GUIDE - POWERPORT IMPLANTABLE PORT, POWERLOC SAFETY INFUSION SET AND EMAILED TO CALLER PER REQUEST. ALSO DISCUSSED CHECKING PORT FOR PATENCY PRIOR TO USE. PROVIDED CUSTOMER SERVICE NUMBER (B)(6) FOR CALLER TO OBTAIN FACILITY SALES REPRESENTATIVE AND THEIR CLINICAL SPECIALISTS CONTACT INFORMATION FOR STAFF EDUCATION AND TRAINING OPTIONS WITH BARD/BD PRODUCTS. SENT CASE TO PRODUCT COMPLAINTS/FA." ADDITIONAL INFO. RECEIVED 07/29/2021 "THE PRODUCT ITSELF IS NOT AN ISSUE. THE QUESTION WAS PROPER TECHNIQUE BEING USED TO GET LAB DRAWS. THE HOSPITAL HAS NEW EQUIPMENT THAT IS ¿MORE SENSITIVE¿ TO THE LAB SAMPLES AND ARE RESULTING AS HEMOLYZED SPECIFIC TO LAB DRAWS FROM PORTS. THE LAB IS ASKING THAT WE USE THE TRANSFER DEVICE HOOKED DIRECTLY TO THE PORT HUB INSTEAD OF DRAWING VIA 10 CC SYRINGE AND TRANSFERRING INTO THE LAB TUBE TO PREVENT HEMOLYSIS. MY INQUIRY WAS NOT DU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351437 ↗
• MalfunctionOct 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO POWERLOCS LEAKED AT THE HUB WHEN IN CT AND PUSHING IN MEDS AT HIGH PRESSURE. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199804 ↗
• MalfunctionOct 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO POWERLOCS LEAKED AT THE HUB WHEN IN CT AND PUSHING IN MEDS AT HIGH PRESSURE. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199795 ↗