• 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 ACE INTRAVASCULAR CATHETER (20G) CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY

  • 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 ACE INTRAVASCULAR CATHETER (20G) CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY Back to Search Results
Model Number N/A
Device Problem Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Date 07/13/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of reeq0703 showed three other similar product complaint(s) from this lot number.
 
Event Description
It was reported "we are training on the device, our clinical nurse specialist was assisting with a placement when she discovered that the device inside the kit was bent on 7/13. Later on in the day we discovered a second device from the same box was also bent. Both devices are defective preventing the guidewire from deploying and the white button from engaging the safety mechanism. Neither device were placed in a patient. " this report addresses the first device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACCUCATH ACE INTRAVASCULAR CATHETER (20G)
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAY
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 Key10368709
MDR Text Key201755592
Report Number3006260740-2020-02766
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162894
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberN/A
Device Catalogue NumberAC1202252
Device Lot NumberREEQ0703
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received09/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-