Per-Q-Cath Plus Catheter 4132100Recalls & reported problems
Bard Access Systems, Inc. · Per-Q-Cath Plus Catheter 2F Single-Lumen PICC with Stiffening Stylet Intermediate Tray (30 cm) · Class 2 · Implant
All models of Per-Q-Cath Plus Catheter (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Per-Q-Cath Plus is a small single-lumen PICC, a long-term intravenous catheter placed through a vein in the arm. The 30 reports mostly describe fluid or blood leaking from the line, the hub separating from the shaft, and the catheter breaking — sometimes during removal or dressing changes, with fragments sometimes left inside the arm. One report describes an injury. There are no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741035210), received between Mar 4, 2016 and May 7, 2022 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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
Device problems
- Fluid/Blood Leak9
- Leak/Splash9
- Break7
- Sticking2
- Detachment of Device or Device Component1
- Disconnection1
- Fracture1
- Hole In Material1
Patient problems
- No Known Impact Or Consequence To Patient15
- No Consequences Or Impact To Patient9
- No Information3
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "WHEN THE CUSTOMER ATTEMPTED TO PRIME THE LINE THEY NOTICED A LEAK NEAR THE HUB OF THE CATHETER." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316008 ↗MalfunctionSep 17, 2020Break; Break
IT WAS REPORTED VIA MED WATCH: "DURING PICC LINE REMOVAL THE PICC LINE SEPARATED FROM THE HUB. THE PICC LINE REMAINED IN THE PATIENT ARM WITH 2 CM PROTRUDING FROM THE ARM. RN ABLE TO REMOVE THE PICC LINE. THE MEASURED PICC LINE MATCHED THE INSERTION LENGTH." ORIGINAL INTENDED PROCEDURE: "PICC LINE REMOVAL"
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10547409 ↗MalfunctionJul 10, 2020Break; Break
IT WAS REPORTED THAT THE PICC LINE CATHETER BROKE IN TWO PIECES NEAR THE HUB. IT WAS STATED NO BROKEN PIECES ENTERED THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10258887 ↗MalfunctionMay 6, 2020Break; Break
IT WAS REPORTED THAT LESS THAN TWO HOURS AFTER PLACEMENT, THE HUB SNAPPED OFF THE PICC LINE. IT WAS STATED IT WAS "REMOVED INTACT AND THE INFANT IS FINE." PLACEMENT INFO: RIGHT AC, TRIMMED AT 14 CM. PICC GOT CURLED UP AND DOUBLED BACK ON ITSELF IN THE AXILLA, ATTEMPTED READJUSTING, REPEATED X-RAY SHOWED IT STILL CURLED, PULLED BACK TO HAVE 6CM EXPOSED OUT OF SKIN, 9CM INSERTED. FLUSHED GREAT AT THE TIME OF PLACEMENT. 90 MINUTES AFTER PLACEMENT THE LINE SNAPPED OFF AT THE HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10028335 ↗InjuryJan 8, 2020Break; Break
IT WAS REPORTED THAT CATHETER BROKE OFF IN PATIENT NEAR INSERTION SITE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9566583 ↗MalfunctionDec 23, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT NURSE WENT TO CHANGE DRESSING WHEN DUE- REMOVED DRESSING AND THE HUB OF THE CATHETER CAME OFF WITH THE DRESSING. CATHETER REMOVED FROM PATIENT AND ANOTHER PICC EXCHANGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513305 ↗MalfunctionDec 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT PICC WAS INSERTED IN PATIENT, BEGAN LEAKING WHEN FLUSHING. PICC WAS PULLED AND ANOTHER PICC PLACED. NO HARM TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9513289 ↗MalfunctionJul 10, 2019Fluid/Blood Leak
IT WAS REPORTED PICC WAS INSERTED IN PATIENT, BEGAN LEAKING WHEN FLUSHING. PICC WAS PULLED AND ANOTHER PICC PLACED, NO HARM TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8777152 ↗MalfunctionMar 1, 2019Leak/Splash
IT WAS REPORTED PICC WAS INSERTED IN PATIENT, BEGAN LEAKING WHEN FLUSHING. PICC WAS PULLED AND ANOTHER PICC PLACED, NO HARM TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8383508 ↗MalfunctionApr 20, 2018Leak/Splash
IT WAS REPORTED THAT WHEN PRIMING THE PICC PRIOR TO INSERTION, THE FACILITY NOTICED A PINHOLE LEAK AROUND THE 10CM MARK. THIS DEVICE WAS NOT USED ON A PATIENT. THEY OPENED ANOTHER PICC AND IT WAS PLACED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7448175 ↗MalfunctionFeb 16, 2018Break
IT WAS REPORTED THAT DURING INSERTION, THE GUIDEWIRE WAS PULLED BACK TO 19CM AND THE CATHETER WAS CUT AT THE 20CM MARK. NURSE HAD DIFFICULTY INSERTING THE CATHETER PAST THE INTRODUCER, AND UPON REMOVAL THE CATHETER BROKE AROUND THE 10CM MARK. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7278548 ↗MalfunctionFeb 6, 2018Fluid/Blood Leak
IT WAS REPORTED THAT WHEN PRIMING THE PICC IT BEGAN LEAKING AT THE 2 CM MARK. THIS OCCURRED BEFORE THE PICC WAS INSERTED, THERE WAS NO CONTACT WITH THE PATIENT. ANOTHER PICC WAS PLACED SUCCESSFULLY.
Patient problems: No Patient Involvement
MAUDE report 7246256 ↗MalfunctionJan 12, 2018Torn Material
IT WAS REPORTED THAT THE PATIENT'S PICC WAS PLACED ON (B)(6) 2017. NURSE REPORTED A TEAR NEAR THE HUB ON (B)(6) 2017, WHILE AT THE PATIENTS HOME. THE PICC WAS REMOVED AND A NEW PICC PLACED. NO PATIENT HARM REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7186283 ↗MalfunctionJan 5, 2018Fluid/Blood Leak
THE FACILITY REPORTED TO THE SALES REP THAT THE RN INSERTED THE PICC AND AFTER REMOVING THE STYLET, A LEAK WAS NOTED AT THE 2CM MARK. THE PICC WAS REMOVED AND ANOTHER PICC WAS PLACED SUCCESSFULLY. NO PATIENT HARM REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7167975 ↗MalfunctionDec 19, 2017Fluid/Blood Leak
IT WAS REPORTED BY THE SALES REP THAT THE FACILITY REPORTED THE CATHETER "SPRUNG" A LEAK AFTER IT WAS PARTIALLY INSERTED INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7132261 ↗MalfunctionDec 19, 2017Leak/Splash
IT WAS REPORTED BY THE SALES REP THAT THE FACILITY REPORTED THE CATHETER "SPRUNG" A LEAK WHILE PRIMING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7132258 ↗MalfunctionDec 19, 2017Disconnection
IT WAS REPORTED BY THE SALES REP THAT THE FACILITY REPORTED A HUB DISCONNECTED FROM THE CATHETER WHEN PRIMING AFTER INSERTION INTO THE PATIENT. THE CATHETER WAS REMOVED AND ANOTHER DEVICE WAS PLACED. NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7131778 ↗MalfunctionNov 16, 2017Hole In Material
IT WAS REPORTED BY THE FACILITY THAT UPON INSERTION OF THE PER-Q-CATH THE NURSE FLUSHED IT AND NOTED A HOLE IN THE CATHETER. THE NURSE COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THE ORIGINAL CATHETER WAS CUT INTO THREE PIECES TO EXCHANGE IT. NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7039769 ↗MalfunctionNov 15, 2017Fluid/Blood Leak
THE FACILITY REPORTED TO THE SALES REP THAT THE PICC NURSE OPENED THE PICC PACKAGING, CONNECTED A SALINE SYRINGE TO PRIME THE PICC, AND NOTICED A LEAK. PRODUCT WAS NOT USED ON A PATIENT, AS IT LEAKED PRIOR TO THE PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 7033303 ↗MalfunctionSep 15, 2017Leak/Splash
PER SALES REP, THE FACILITY REPORTED THAT DURING PRIMING OF THE CATHETER IT LEAKED, SQUIRTING OUT SALINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6870114 ↗MalfunctionSep 15, 2017Leak/Splash
PER SALES REP, THE FACILITY REPORTED THAT DURING PRIMING OF THE CATHETER IT LEAKED, SQUIRTING OUT SALINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6870086 ↗MalfunctionSep 15, 2017Leak/Splash
PER SALES REP, THE FACILITY REPORTED THAT DURING PRIMING OF THE CATHETER IT LEAKED, SQUIRTING OUT SALINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6870051 ↗MalfunctionSep 15, 2017Leak/Splash
PER SALES REP, THE FACILITY REPORTED THAT DURING PRIMING OF THE CATHETER IT LEAKED, SQUIRTING OUT SALINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6870047 ↗MalfunctionJul 13, 2017Leak/Splash
FACILITY REPORTED TO THE SALE REP THAT PRIOR TO USE ON PATIENT THE HEALTHCARE PROFESSIONAL FLUSHED THE CATHETER AND NOTED LEAKING. HEALTHCARE PROFESSIONAL STATES THE LEAK IS NOTED PRIOR TO WIRE MOVEMENT. THIS REPORT ADDRESSES CATHETER ONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6710351 ↗MalfunctionJul 13, 2017Fluid/Blood Leak
FACILITY REPORTED TO THE SALES REP THAT PRIOR TO USE ON PATIENT THE HEALTHCARE PROFESSIONAL FLUSHED THE CATHETER AND NOTED LEAKING. HEALTHCARE PROFESSIONAL STATES THE LEAK IS NOTED PRIOR TO WIRE MOVEMENT. THIS REPORT ADDRESSES CATHETER TWO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6710342 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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