Portex 100/399/218Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00351688068142), received between Dec 11, 2018 and Oct 12, 2022 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PLASTIC CATHETER SECUREMENT DEVICE DISLODGED FROM THE SOFT DRESSING . THE RUPTURE OF THE DEVICE LED TO AN ACCIDENTAL REMOVAL OF THE CATHETER. A SECOND EPIDURAL CATHETER HAD TO BE INSERTED. NO FURTHER INCIDENT OBSERVED AFTERWARD. INCIDENT REPORTEDLY OCCURS AT A FREQUENCY RANGE OF 1 TO 4 TIMES PER MONTH. ADDITIONAL INFORMATION RECEIVED ON 29-SEP-2022: THE DEVICE WAS CHANGED. NO FURTHER ISSUE OBSERVED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15587370 ↗
• MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PLASTIC CATHETER SECUREMENT DEVICE DISLODGED FROM THE SOFT DRESSING. THE RUPTURE OF THE DEVICE LED TO AN ACCIDENTAL REMOVAL OF THE CATHETER. A SECOND EPIDURAL CATHETER HAD TO BE INSERTED. NO FURTHER INCIDENT OBSERVED AFTERWARD. INCIDENT FREQUENCY REPORTEDLY RANGES FROM 1 TO 4 TIMES PER MONTH. ADDITIONAL INFORMATION RECEIVED ON 29-SEP-2022: DEVICE WAS CHANGED. NO FURTHER ISSUE OBSERVED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15581994 ↗
• MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PLASTIC CATHETER SECUREMENT DEVICE DISLODGED FROM THE SOFT DRESSING. THE RUPTURE OF THE DEVICE LED TO AN ACCIDENTAL REMOVAL OF THE CATHETER. A SECOND EPIDURAL CATHETER HAD TO BE INSERTED. NO FURTHER INCIDENT OBSERVED AFTERWARD. INCIDENT FREQUENCY RANGE IS REPORTEDLY 1 TO 4 TIMES PER MONTH. ADDITIONAL INFORMATION RECEIVED ON 29-SEP-2022: DEVICE WAS CHANGED. NO FURTHER ISSUE OBSERVED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15580851 ↗
• MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PLASTIC CATHETER SECUREMENT DEVICE DISLODGED FROM THE SOFT DRESSING. THE RUPTURE OF THE DEVICE LED TO AN ACCIDENTAL REMOVAL OF THE CATHETER. A SECOND EPIDURAL CATHETER HAD TO BE INSERTED. NO FURTHER INCIDENT OBSERVED AFTERWARD. ADDITIONAL INFORMATION RECEIVED ON 29-SEP-2022: DEVICE WAS CHANGED. NO FURTHER ISSUE OBSERVED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15580840 ↗
• MalfunctionAug 29, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE CATHETER FELL OUT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316107 ↗
• MalfunctionAug 26, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE LID WAS UNABLE TO BE CLOSED, WHICH DID NOT ALLOW HIM TO USE IT PROPERLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299984 ↗
• MalfunctionJul 12, 2022Fracture; Device Contamination with Body Fluid; Fracture; Device Contamination with Body Fluid

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED IT WAS BROKEN. A BLOOD MARK WAS FOUND ON IT. NO PATIENT INJURY OR ADVERSE AFFECTS. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986294 ↗
• InjuryDec 11, 2018Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX LOCKIT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE BECAME DETACHED WHILE IN USE WITH A PATIENT. THE REPORTER STATED THE DETACHMENT RESULTED IN THE CATHETER PULLING OUT OF THE EPIDURAL SPACE, WHICH CAUSED THE EPIDURAL PAIN CONTROL TO BE INSUFFICIENT. SUBSEQUENTLY, THE NURSES HAD TO INSERT A NEW EPIDURAL CATHETER AND A MORE INVASIVE METHOD OF ANESTHESIA INTERVENTION WAS REQUIRED, NOTED AS EITHER, "GENERAL ANESTHESIA OR EMERGENCY CESAREAN SECTION". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Awareness During Anesthesia

  MAUDE report 8152168 ↗
• InjuryDec 11, 2018Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX LOCKIT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE BECAME DETACHED WHILE IN USE WITH A PATIENT. THE REPORTER STATED THE DETACHMENT RESULTED IN THE CATHETER PULLING OUT OF THE EPIDURAL SPACE, WHICH CAUSED THE EPIDURAL PAIN CONTROL TO BE INSUFFICIENT. SUBSEQUENTLY, THE NURSES HAD TO INSERT A NEW EPIDURAL CATHETER AND A MORE INVASIVE METHOD OF ANESTHESIA INTERVENTION WAS REQUIRED, NOTED AS EITHER, "GENERAL ANESTHESIA OR EMERGENCY CESAREAN SECTION". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Awareness During Anesthesia

  MAUDE report 8152166 ↗
• InjuryDec 11, 2018Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX LOCKIT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE BECAME DETACHED WHILE IN USE WITH A PATIENT. THE REPORTER STATED THE DETACHMENT RESULTED IN THE CATHETER PULLING OUT OF THE EPIDURAL SPACE, WHICH CAUSED THE EPIDURAL PAIN CONTROL TO BE INSUFFICIENT. SUBSEQUENTLY, THE NURSES HAD TO INSERT A NEW EPIDURAL CATHETER AND A MORE INVASIVE METHOD OF ANESTHESIA INTERVENTION WAS REQUIRED, NOTED AS EITHER, "GENERAL ANESTHESIA OR EMERGENCY CESAREAN SECTION". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Awareness During Anesthesia

  MAUDE report 8151930 ↗
• InjuryDec 11, 2018Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX LOCKIT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE BECAME DETACHED WHILE IN USE WITH A PATIENT. THE REPORTER STATED THE DETACHMENT RESULTED IN THE CATHETER PULLING OUT OF THE EPIDURAL SPACE, WHICH CAUSED THE EPIDURAL PAIN CONTROL TO BE INSUFFICIENT. SUBSEQUENTLY, THE NURSES HAD TO INSERT A NEW EPIDURAL CATHETER AND A MORE INVASIVE METHOD OF ANESTHESIA INTERVENTION WAS REQUIRED, NOTED AS EITHER, "GENERAL ANESTHESIA OR EMERGENCY CESAREAN SECTION". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Awareness During Anesthesia

  MAUDE report 8151924 ↗