Peripheral Catheter Insertion Kit AC0201250Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741110917), received between Jul 11, 2016 and Jun 25, 2020 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING TESTING OF THE DEVICES AT THE FACILITY, THE NEEDLE WOULD NOT RETRACT ON TWO ACCUCATHS. THE DEVICES WERE NOT USED ON A PATIENT. .

  Patient problems: No Patient Involvement

  MAUDE report 10197325 ↗
• MalfunctionJun 25, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING TESTING OF THE DEVICES AT THE FACILITY, THE NEEDLE WOULD NOT RETRACT ON TWO ACCUCATHS. THE DEVICES WERE NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10197320 ↗
• MalfunctionJan 9, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE ACCUCATH NEEDLE NOT RETRACTING PROPERLY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9570251 ↗
• MalfunctionNov 25, 2019Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE OF THE ACCUCATH DID NOT RETRACTING PROPERLY INTO SAFETY SHIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372477 ↗
• MalfunctionNov 19, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO USE WHEN OPENING THE PACKAGE, END-USER NOTICED THE CATHETER BENT AT HUB OF CATHETER. PRODUCT WAS QUARANTINED AND NOT USED ON PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9344744 ↗
• MalfunctionAug 30, 2019Defective Device

  IT WAS REPORTED THAT THE PLACER CHECKED THE ACCUCATH WIRE PRIOR TO DEPLOYMENT BY PUSHING IT OUT AND FULLY RETRACTING IT BACK IN THE NEEDLE TIP. IT WAS STATED THAT THE PLACER STUCK THE PATIENT, DEPLOYED THE GUIDEWIRE AND CATHETER WITH NO ISSUES OR RESISTANCE NOTED. WHILE ATTEMPTING TO SAFETY THE DEVICE, THE ACCUCATH WOULD NOT FULLY SAFETY. THE ENTIRE DEVICE AND CATHETER WERE REMOVED TOGETHER. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8951897 ↗
• InjuryOct 19, 2018Migration or Expulsion of Device

  IT WAS REPORTED THAT THE ACCUCATH WAS PLACED IN PATIENTS RIGHT AC ON (B)(6) 2018. ON (B)(6) 2018 WHEN LINE WAS BEING FLUSHED, THE BEDSIDE RN NOTICED THAT THE IV WAS NO LONGER INTACT AND NOTIFIED PHYSICIAN, NURSE MANAGER. PATIENT UNDERWENT MULTIPLE EXAMS UNTIL CATHETER WAS FOUND IN HER RIGHT AC. PATIENT WAS TAKEN TO SURGERY LATER THAT AFTERNOON TO HAVE THE CATHETER SURGICAL REMOVED.

  Patient problems: No Code Available

  MAUDE report 7985673 ↗
• InjuryAug 24, 2018Break; Component Missing; Detachment of Device or Device Component; Physical Resistance/Sticking

  CLINICAL SPECIALIST STATES SHE WAS ASSISTING A NURSE INSERT AN ACCUCATH. SHE STATES THE NURSE WAS UNABLE TO PLACE THE CATHETER DUE TO RESISTANCE. UPON REMOVING THE CATHETER THEY NOTED THE CURL ON THE TIP OF THE GUIDEWIRE WAS MISSING. MS&S DISCUSSED PLACEMENT TECHNIQUE. THE FACILITY CALLED AND STATED THAT THE FRAGMENT OF THE WIRE BROKEN OFF AND REMAINED IN THE PATIENT. THE PATIENT HAD TO HAVE THE FRAGMENT REMOVED BY A SURGEON IN THE IR DEPARTMENT. 09/11/2018 PER MEDWATCH: ATTEMPTED TO INSERT A 20G X 1.25 INCH ACCUCATH INTO LEFT LOWER CEPHALIC VEIN AND WAS UNSUCCESSFUL. AFTER ACTIVATING THE SAFETY FEATURE, THE COIL TIP GUIDEWIRE WAS EXAMINED. COIL OF THE GUIDEWIRE WAS NOT PRESENT. INSPECTED THE INSERTION SITE AND A BUMP WAS NOTED AT THE SITE. IT APPEARED TO BE THE COIL OF THE TIP. SURGICAL WAS CONSULTED AND REMOVED THE COILED TIP FROM THE LEFT LOWER FOREARM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7813748 ↗
• MalfunctionMar 21, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT: "CATHETER INSERTED IN AC SPACE OF THE ARM, FLUSHED EASILY AND HAD RELIABLE BLOOD RETURN, PATIENT RECEIVED A CT SCAN WITH POWER CONTRAST AT 300 PSI AND 3.2 ML/SEC AND PART OF THE INJECTION WAS SUCCESSFUL AND BUT A SIGNIFICANT AMOUNT OF THE CONTRAST WAS INJECTED OUTSIDE OF THE VEIN AND CAUSED AN INFILTRATION. TEST WAS STILL SUCCESSFUL. WE SPECULATED THAT NOT MUCH OF THE CATHETER WAS IN THE VEIN AND THE PRESSURE FROM THE CONTRAST INJECTION FORCED THE CATHETER BACK AND OFF OF THE VESSEL." NO PATIENT INJURY REPORTED.

  Patient problems: Infiltration into Tissue

  MAUDE report 7357768 ↗
• MalfunctionNov 29, 2017Device Operates Differently Than Expected

  IT WAS REPORTED BY THE FACILITY, THAT THE HEALTHCARE PROFESSIONAL WAS PERFORMING A TRAINING WITH THE DEVICE. WHEN THE CAP WAS REMOVED THE CATHETER PULLED OUT AND REMAINED INSIDE THE CAP. DEVICE WAS NOT USED ON PATIENT. THIS FILE ADDRESSES DEVICE THREE OF FIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068386 ↗
• MalfunctionNov 29, 2017Device Operates Differently Than Expected

  IT WAS REPORTED BY THE FACILITY, THAT THE HEALTHCARE PROFESSIONAL WAS PERFORMING A TRAINING WITH THE DEVICE. WHEN THE CAP WAS REMOVED THE CATHETER PULLED OUT AND REMAINED INSIDE THE CAP. DEVICE WAS NOT USED ON PATIENT. THIS FILE ADDRESSES DEVICE FOUR OF FIVE.

  Patient problems: No Patient Involvement

  MAUDE report 7068385 ↗
• MalfunctionNov 29, 2017Device Operates Differently Than Expected

  IT WAS REPORTED BY THE FACILITY, THAT THE HEALTHCARE PROFESSIONAL WAS PERFORMING A TRAINING WITH THE DEVICE. WHEN THE CAP WAS REMOVED THE CATHETER PULLED OUT AND REMAINED INSIDE THE CAP. DEVICE WAS NOT USED ON PATIENT. THIS FILE ADDRESSES DEVICE FIVE OF FIVE.

  Patient problems: No Patient Involvement

  MAUDE report 7068383 ↗
• MalfunctionNov 29, 2017Device Operates Differently Than Expected

  IT WAS REPORTED BY THE FACILITY, THAT THE HEALTHCARE PROFESSIONAL WAS PERFORMING A TRAINING WITH THE DEVICE. WHEN THE CAP WAS REMOVED THE CATHETER PULLED OUT AND REMAINED INSIDE THE CAP. DEVICE WAS NOT USED ON PATIENT. THIS FILE ADDRESSES DEVICE TWO OF FIVE.

  Patient problems: No Patient Involvement

  MAUDE report 7068377 ↗
• MalfunctionNov 29, 2017Device Operates Differently Than Expected

  IT WAS REPORTED BY THE FACILITY, THAT THE HEALTHCARE PROFESSIONAL WAS PERFORMING A TRAINING WITH THE DEVICE. WHEN THE CAP WAS REMOVED THE CATHETER PULLED OUT AND REMAINED INSIDE THE CAP. DEVICE WAS NOT USED ON PATIENT. THIS FILE ADDRESSES DEVICE ONE OF FIVE.

  Patient problems: No Patient Involvement

  MAUDE report 7068369 ↗
• MalfunctionAug 3, 2017Break

  IT WAS REPORTED BY THE FACILITY, VIA THE SALES REP, THAT THE NURSE WAS CONSULTED FOR A PATIENT THAT NEEDED IV ACCESS. THE PATIENT HAD ALREADY BEEN SEEN BY THE DAY SHIFT AND HAD AN ACCUCATH PLACED. WHEN THE NURSE TALKED TO A SECOND NURSE HE REPORTED TO HER THAT THE HUB OF THE ACCUCATH BROKE AWAY FROM THE CATHETER. THE CATHETER WAS STILL IN THE PATIENT'S ARM WITH BLOOD SPEWING OUT, PER THE BEDSIDE NURSE. THE CATHETER WAS REMOVED BY THE NURSE IN ITS ENTIRETY. THE NURSE REPORTED THAT WHEN SHE ENTERED THE PATIENT'S ROOM, THE HUB WAS TILL CONNECTED TO THE IV TUBING. A SECOND FILE WAS OPENED, AS ANOTHER ACCUCATH WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6765568 ↗
• MalfunctionMay 23, 2017Hole In Material; Leak/Splash

  AS REPORTED BY NURSE AT THE FACILITY, THEY NOTICED THAT THERE WAS A HOLE IN THE PROXIMAL THIRD OF THE CATHETER WHERE BLOOD WAS DRIPPING OUT BEFORE FULLY THREADING THE CATHETER IN THE VEIN. WHEN HE NOTICED THE LEAKING, HE REMOVED THE CATHETER FROM THE PATIENT AND PLACED ANOTHER IV. THE PATIENT WAS NOT HARMED.

  Patient problems: Blood Loss

  MAUDE report 6584610 ↗
• InjuryMar 8, 2017Break; Fluid/Blood Leak; Migration or Expulsion of Device

  SALES REP REPORTED THAT WHILE AT THE FACILITY DURING TRAINING ON (B)(6) 2017, THE HEALTHCARE PROFESSIONAL PLACED THE DEVICE AND THE PROCEDURE WENT WELL. THE FACILITY CONTACTED THE SALES REP ON (B)(6) 2017, AND STATED THAT THE CATHETER BROKE OFF AT THE HUB AND MIGRATED. SURGERY WILL BE REQUIRED FOR REMOVAL. NO PATIENT HARM WAS REPORTED. ON 2/17/2017 - ADDITIONAL INFORMATION RECEIVED FROM BARD CLINICAL SPECIALIST. SHE REPORTED THAT SHE WAS PRESENT AT TIME OF PLACEMENT. THE CATHETER WAS PLACED WITHOUT ANY COMPLICATIONS AND WAS PRESENT IN THE PATIENT'S VEIN. DEVICE WAS PLACED AT 10:00 AM ON WEDNESDAY, (B)(6) 2017. THE PATIENT WAS TRANSFERRED FROM THE EMERGENCY ROOM TO THE INPATIENT FLOOR. WHEN THE NIGHT NURSE CHECKED THE PATIENT'S DRESSING AT 7:00 PM, THE NURSE STATED THE PATIENT'S DRESSING WAS WET. THE DRESSING WAS PARTIALLY LIFTED AND THE NURSE NOTED SOME LEAKING AND CHECKED THE EXTENSIONS. A NEW IV WAS PLACED. NURSE THEN REPORTED THE DRESSING WAS COMPLETELY SOAKED THROUGH. SHE REMOVED THE DRESSING AND NOTED THE CATHETER WAS MISSING. NURSE STATED THE CATHETER WAS NO WHERE TO BE SEEN ON THE OUTSIDE OF THE PATIENT'S BODY. AN X-RAY AND ULTRASOUND WAS DONE ON THE PATIENT'S ARM AND CHEST

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6388844 ↗
• MalfunctionDec 16, 2016Detachment Of Device Component

  IT WAS REPORTED BY THE NURSE THAT AFTER GIVING A "GOOD FLUSH" THE CATHETER SEPARATED FROM THE HUB. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6183510 ↗
• MalfunctionJul 11, 2016Break; Improper or Incorrect Procedure or Method

  AS REPORTED TO THE SALES REPRESENTATIVE BY THE FACILITY, THE CATHETER WAS PUNCTURED AND WIRE FORCED INTO THE SCAR TISSUE. THE WIRE WAS SAID TO HAVE SNAPPED DURING REMOVAL FROM THE PATIENT AND THE TIP OF WIRE WAS WRAPPED AROUND DISTAL TIP OF CATHETER. ON (B)(6) 2016 - ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE: A CONVENTIONAL IV WAS PLACED. THEY STATED THAT THIS EVENT MAY BE USER-ERROR AS IT LOOKS LIKE CATHETER SHEARED WITH EXCESSIVE MANIPULATION AND THE WIRE WAS FORCED BY CLINICIAN DURING PLACEMENT. CLINICIAN STATED THAT IT FELT "WEIRD" AND WAS DIFFICULT TO PLACE AND THREAD THROUGH SCAR TISSUE ONCE INSIDE. CLINICIAN REMOVED THE STUCK CATHETER BY PLACING A TOURNIQUET AND PULLING ON THE DEVICE WHICH "TOOK TIME AND FORCE".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5784341 ↗