PremierPro™ 31TB20100Recalls & reported problems
Prestige Ameritech, Ltd. · PremierPro™ by MedSource TrueSafe Comfort® Blood Control Safety IV Catheter, 20G x 1in, 1 each · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811220034795), received between Jun 26, 2024 and Jun 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Disconnection1
- Failure to Advance1
- Loose or Intermittent Connection1
- Product Quality Problem1
- Retraction Problem1
Patient problems
- Extravasation1
- Infiltration into Tissue1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2024Disconnection; Loose or Intermittent Connection; Product Quality Problem; Difficult to Remove; Retraction Problem; Failure to Advance
MULTIPLE ISSUES WITH THE TRUESAFE COMFORT BLOOD CONTROL IV CATHETER. REPORTS CONTAIN ALL GAUGE CATHETERS. VARIOUS COMPLAINTS: 1. CATHETER WOULD NOT ADVANCE 2. CATHETER RETRACTED EARLY CAUSING THE VEIN TO BLOW 3. INFILTRATIONS 4. CATHETER DOES NOT CONNECT TO TUBING CONNECTION WELL 5. DURING PRESSURE INJECTION CT; THE CATHETER AND CONNECTION DISCONNECT. 6. IV NEED WOULD NOT RETRACT AFTER STARTING IV. HAD TO PULL THE ENTIRE DEVICE OUT OF THE PATIENT'S ARM TO RETRACT THE NEEDLE.
Patient problems: Extravasation; Infiltration into Tissue
MAUDE report 19613246 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.