PowerLoc 0672034JRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741151477), received between Apr 24, 2018 and Aug 7, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177249 ↗
• MalfunctionSep 10, 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. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10518838 ↗
• MalfunctionApr 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE NEEDLE OF POWERLOC WAS ACCESSED TO THE PORT SYSTEM, THE NEEDLE WAS NOT STABLE. THE NURSE GUESSED THAT IT WAS BECAUSE THE "SHIELD" ARM WAS NOT FITTED TO THE "SHIELD" BASE "COMPLETELY". THERE WAS NO REPORTED PATIENT INJURY. IT WAS STATED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSED THE SECOND OF TWO DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9921394 ↗
• MalfunctionApr 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE NEEDLE OF POWERLOC WAS ACCESSED TO THE PORT SYSTEM, THE NEEDLE WAS NOT STABLE. THE NURSE GUESSED THAT IT WAS BECAUSE THE "SHIELD" ARM WAS NOT FITTED TO THE "SHIELD" BASE "COMPLETELY". THERE WAS NO REPORTED PATIENT INJURY. IT WAS STATED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSED THE FIRST OF TWO DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9921392 ↗
• MalfunctionNov 25, 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 9371451 ↗
• MalfunctionNov 11, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT THE NURSE STOPPED USING THE POWERLOC TO THE PATIENT BECAUSE THE NEEDLE WAS LOOSE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9305764 ↗
• MalfunctionOct 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE POWERLOC WAS PRIMED BEFORE USE TO THE PATIENT, SALINE SOLUTION LEAKED FROM THE VICINITY OF THE CONNECTION BETWEEN THE TUBE AND THE NEEDLE HOUSING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234335 ↗
• MalfunctionAug 15, 2019Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING ADMINISTRATION OF MEDICINES FROM THE CONNECTOR AT THE Y SITE AND ADMINISTRATION OF TPN FROM THE CONNECTOR AT THE EXTENSION TUBE SIMULTANEOUSLY, LEAKAGE FROM THE Y SITE WAS FOUND APPROXIMATELY TWO HOURS AFTER THE START OF ADMINISTRATION. WHEN THE POWERLOC WAS REMOVED AND WATER WAS INJECTED USING A 6CC SYRINGE, A CRACK WAS FOUND AT THE Y SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896977 ↗
• MalfunctionAug 9, 2019Component Missing

  IT WAS REPORTED THAT WHEN OPENING THE KIT, 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 8879676 ↗
• MalfunctionJul 31, 2019Crack; Leak/Splash

  IT WAS REPORTED THAT WHEN HEPARINIZED SALINE SOLUTION WAS INJECTED INTO THE POWERLOC TO LOCK THE PORT SYSTEM, THERE WAS A CRACK AT THE Y SITE OF THE POWERLOC AND HEPARINIZED SALINE SOLUTION LEAKED FROM THE CRACK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8846105 ↗
• MalfunctionJul 23, 2019Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE CONTRAST CT EXAMINATION AFTER THE NEEDLE OF POWER LOCK WAS ACCESSED TO THE PORT BODY OF POWERPORT, THE PHYSICIAN FOUND THAT BLOOD VESSEL WAS NOT BE DISPLAYED. THEREFORE, THE LINE WAS CHECKED AND IT WAS TURNED OUT THAT THE CAP WAS DETACHED FROM THE CONNECTOR OF UNCONNECTED SIDE AND THE CONTRAST MEDIUM WAS LEAKED FROM THE CONNECTOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8818893 ↗
• MalfunctionMay 9, 2019Component Missing

  IT WAS REPORTED THAT WHEN OPENING THE KIT, IT WAS NOTICED THAT THE COVER OF NEEDLE WAS NOT CONTAINED IN IT. THE FACILITY IS REQUESTING THE ANSWERS IF THERE ARE ANY SAME ISSUES REPORTED REGARDING THE SAME LOT AND WHAT THE POSSIBLE CAUSE OF THE ISSUE IS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8597519 ↗
• MalfunctionDec 7, 2018Scratched Material

  IT WAS REPORTED THAT WHEN A PACKAGE OF POWERLOC WAS OPENED, A NEEDLE COVER DIDN'T PROTECT THE NEEDLE AND A EXPOSED TIP OF THE NEEDLE STUCK THE NURSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8143071 ↗
• MalfunctionAug 9, 2018Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OF CONTRAST WAS FOUND OUTSIDE OF THE BODY AFTER CONTRAST CT EXAMINATION. THEREFORE, THE NURSE REMOVED POWERLOC NEEDLE FROM THE PORT BODY OF POWERPORT. WHEN THE NURSE CONFIRMED THE REMOVED NEEDLE, S/HE FOUND THAT THE LEAKAGE HAD COME FROM THE JOINT OF THE WING PART. THERE WERE NO ABNORMALITIES FOUND WHEN S/HE FLUSHED AND CHECKED BLOOD RETURN BEFORE THE CONTRAST CT EXAMINATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7770734 ↗
• MalfunctionAug 9, 2018Unstable

  IT WAS REPORTED THAT THE NEEDLE BASE WAS UNSTABLE. A NEW NEEDLE WAS OPENED AND WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7770697 ↗
• MalfunctionMay 4, 2018Detachment Of Device Component

  IT WAS REPORTED THAT "THE TUBE WAS DETACHED FROM THE WING PART". NO ADDITIONAL INFORMATION PROVIDED. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7487518 ↗
• MalfunctionApr 27, 2018Detachment Of Device Component; Unstable; Material Protrusion/Extrusion

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE NEEDLE PROTECT COVER CAME OFF THE NEEDLE AND DROPPED. THE OPERATOR COMPLAINED THAT S/HE STOPPED USING THE DEVICE BECAUSE ITS WING PART WAS APART FROM THE SHIELD BASE AND ITS NEEDLE WAS EXPOSED AND UNSTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7468185 ↗
• MalfunctionApr 24, 2018Component Missing

  IT WAS REPORTED THAT THE NEEDLE PROTECT COVER WAS NOT ATTACHED TO THE NEEDLE FROM THE BEGINNING. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7456334 ↗