• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Positioning Problem (3009); Physical Resistance/Sticking (4012)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that "icu rn was placing an accucath on the evening of aug 4th or morning of aug 5th during her night shift. She scanned the vein and identified a valve so stuck below it. Accessed the vein and saw the needle tip in it. Advanced the wire. It went smooth most of the way but resistance was met towards the end. Patient did not alert that there was any pain so she continued to advance. Began to thread the catheter and the patient said it hurt. She stopped and the catheter, then pull the device out. Once it was out, she noticed that the catheter wasn¿t as long as it should be. They identified that the catheter tip was in the tissue and could actually see it. Lidocaine was administered and they removed it with tweezers. No patient harm. She proceeded to place a 2nd accucath successfully. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key8950951
MDR Text Key156167211
Report Number3006260740-2019-02561
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberAC0202250
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/30/2019 Patient Sequence Number: 1
-
-