Peripheral Catheter Insertion Kit F320108TRecalls & reported problems
Bard Access Systems, Inc. · PowerGlide 20Ga, 10cm · Class 2
All models of Peripheral Catheter Insertion Kit (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741140730), received between Oct 1, 2021 and Nov 13, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak3
- Improper or Incorrect Procedure or Method1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2023Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
IT WAS REPORTED BY CUSTOMER THAT MIDLINE CATHETER LEAKING AT HUB OF CATHETER. PICC NURSE NOTED THAT WHEN LINE FLUSHED WITH NORMAL SALINE, IT LEAKED BACK OUT FROM THE HUB. NURSES HAVE NOTICED THAT IN GENERAL THIS PRODUCT HAS ISSUES WITH KINKING AND/OR TWISTED AT THE HUB OF THE CATHETER WITH SEVERAL PATIENTS. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18124656 ↗MalfunctionMar 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "MIDLINE CATHETER LEAKING AT HUB OF CATHETER. PICC NURSE NOTED THAT WHEN LINE FLUSHED WITH NORMAL SALINE, IT LEAKED BACK OUT FROM THE HUB." PLACEMENT DATE:(B)(6) 2022. EXPLANT DATE: N/A WAS THERE ANY PATIENT HARM REPORTED? NO IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME. AT WHAT POINT DURING DEVICE USE WAS THE LEAK DISCOVERED (I.E. INSERTION, INFUSION, REMOVAL) PICC NURSE NOTED THAT WHEN LINE FLUSHED WITH NORMAL SALINE, IT LEAKED BACK OUT FROM THE HUB. WAS THE CATHETER FRACTURE INTERNAL TO THE PATIENT OR EXTERNAL? UNKNOWN WHAT WAS INFUSION WHEN THE LEAK WAS DISCOVERED? SALINE ANY PATIENT SYMPTOMS RELATED TO FLUID LEAK? UNKNOWN WAS THE CATHETER REMOVED? YES WAS A NEW CATHETER PLACED? YES WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13905265 ↗MalfunctionOct 1, 2021Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method
IT WAS REPORTED "WHEN DOING POWERGLIDE TRAINING, DURING A BEDSIDE INSERTION, CATHETER WAS PLACED WITHOUT DIFFICULTLY (NO RESHEATHING OF CATHETER OR STRESS TO DEVICE NOTED). AFTER CATHETER WAS ADVANCED ATTEMPTED TO ASPIRATE BLOOD RETURN AND AIR WAS NOTED ENTERING THE SYRINGE. INSURED THAT EXTENSION SET WAS SECURE AND PROPERLY ATTACHED. AGAIN ATTEMPTED TO ASPIRATE FOR BLOOD RETURN AND AIR AGAIN NOTED ENTERING THE SYRINGE, WHEN FLUSHING CATHETER WAS NOTED TO BE LEAKING WHERE THE CATHETER JOINS THE HUB. CATHETER DC'ED INTACT WITH NO INJURY TO PATIENT." ADD INFO RCVD 09/17/2021: WHAT THEY¿RE BEING TREATED FOR: RHABDOMYOLYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12565291 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page