PowerLoc 0671934JRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741151453), received between Jun 14, 2018 and Nov 4, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Contamination /Decontamination Problem; No Apparent Adverse Event; Contamination /Decontamination Problem; No Apparent Adverse Event

  IT WAS REPORTED UPON OPENING, FOREIGN MATTER SUCH AS CARDBOARD FRAGMENTS WAS FOUND. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469659 ↗
• MalfunctionJun 30, 2020Misassembled; Misassembled

  IT WAS REPORTED THAT IT WAS FOUND THAT THE NEEDLE COVER WAS DETACHED FROM THE NEEDLE, SO THAT THE NEEDLE TIP WAS UNCOVERED UPON OPENING THE PACKAGE. THE DEVICE WAS DISCARDED WITH SAFETY LOCKED FOR SAFE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10214469 ↗
• MalfunctionJan 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CLAMP ON THE UNUSED SIDE TUBE WAS SUDDENLY OPENED DURING INFUSION OF CONTRAST MEDIUM THROUGH THE MAIN ROUTE, AND THE CONTRAST MEDIUM WAS LEAKED FROM THE POWERLOC. THE FACILITY REQUESTS US TO INSPECT WHETHER THE CLAMP OR TUBE IS DEFECTIVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560476 ↗
• MalfunctionDec 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CONTRACT MEDIUM WAS INFUSED VIA THE POWERLOC FOR MRI EXAMINATION. WHEN THE PATIENT RETURNED TO THE WARD AFTER THE EXAMINATION WAS COMPLETED, IT WAS FOUND THAT AIR WAS CONTAMINATED INTO THE INFUSION LINE. ALTHOUGH THE PATIENT'S CONDITION ALLEGEDLY GOT WORSE TEMPORARILY BECAUSE OF AIR CONTAMINATION INTO THE PATIENT'S BODY, IT HAS BEEN RECOVERED AND IS STABLE NOW. THE FACILITY GUESSED THAT AIR EMBOLISM OCCURRED DUE TO THE LOOSE CONNECTION BETWEEN THE LURE CONNECTOR AT THE Y-SITE AND THE INFUSION LINE OF CONTRAST MEDIUM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492228 ↗
• MalfunctionSep 19, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, IT WAS NOTICED THAT THE COVER OF NEEDLE WAS NOT CONTAINED IN IT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9088498 ↗
• MalfunctionJul 10, 2019Leak/Splash

  IT WAS REPORTED THAT WHEN THE NEEDLE OF POWERLOC WAS ACCESSED TO THE PORT BODY OF POWERPORT AND CONTRAST MEDIUM WAS INFUSED, BACK FLOW OF THE CONTRAST MEDIUM TO THE LUER CONNECTOR ON THE UNUSED SIDE WAS FOUND. IT WAS FURTHER REPORTED THAT ALTHOUGH THE CAP OF THE UNUSED LUER CONNECTOR HAD BEEN CLOSED, THE CONTRAST MEDIUM LEAKED FROM THE GAP OF THE CAP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777264 ↗
• MalfunctionFeb 14, 2019Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE OF POWER LOCK WAS ACCESSED TO THE PORT BODY OF POWER-PORT AND MEDICATION WAS ADMINISTERED ON (B)(6) 2019. BECAUSE THE MEDICINE WAS DIFFICULT TO INFUSE, THE CONTRASUT EXAMINATION WAS PERFORMED AFTER COMPLETION FO THE MEDICATION. HOWEVER, THERE WAS NO LEAKAGE NOR DAMAGE FOUND BY CT. AFTER THE FLUSHING, MEDICATION HAD NOT DONE FOR SIX DAYS THOUGH THE NEEDLE WAS LEFT TO ACCESS TO THE PORT BODY. IT WAS FURTHER REPORTED THAT WHEN FLUSH WAS CONDUCTED BEFORE STARTING MEDICATION ON (B)(6) 2019, THE LEAKAGE WAS FOUND NEAR THE CONNECTION BETWEEN THE HUB OF THE NEEDLE AND THE SYRINGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8340929 ↗
• MalfunctionSep 12, 2018Complete Blockage; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE POWERLOC WAS ACCESSED TO THE PORT BODY OF POWERPORT AND CONTRAST MEDIUM WAS TRIED TO INFUSE. HOWEVER, CONTRAST MEDIUM COULD NOT BE INFUSED INTO THE PORT SYSTEM. IT WAS STATED FOREIGN MATERIAL WHICH LOOKED LIKE A PART OF SEPTUM WAS FOUND AT THE TIP OF NEEDLE WHEN POWERLOC NEEDLE WAS REMOVED FROM THE PORT BODY OF POWERPORT. THE OPERATOR INFERRED THAT SEPTUM WAS CORED BY HUBER NEEDLE, WHICH MAY HAVE BEEN CAUSE NEEDLE OCCLUSION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7870743 ↗
• MalfunctionJun 14, 2018Backflow; Improper Flow or Infusion

  IT WAS REPORTED THAT CONTRAST MEDIUM ALLEGEDLY FLOWED BACK THROUGH THE SUB ROUTE OF THE POWERLOC. REPORTEDLY, DURING CT IMAGING WITH THE POWERPORT MRI ISP AND THE POWERLOC, WHEN INFUSING CONTRAST MEDIUM INTO THE MAIN ROUT OF THE POWERLOC, THE MEDIUM ALLEGEDLY FLOWED BACK FROM THE SUB ROUTE. REPORTEDLY, PRIOR TO INFUSION, THE OPERATOR EXCHANGED THE CAP ATTACHED TO THE SUB ROUTE FOR A NON-PRESSURE INJECTION CAP, CONNECTED A SYRINGE, CONFIRMED BLOOD BACKFLOW, AND FLUSHED THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602600 ↗