• 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, 18GX1.25 BASIC 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, 18GX1.25 BASIC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Entrapment of Device (1212); Sticking (1597); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred. A lot history review (lhr) of reax0791 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the end of the coil tip gets stuck inside device and comes out as a "big loop of wire. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACCUCATH, 18GX1.25 BASIC
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
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key7652850
MDR Text Key112996516
Report Number3006260740-2018-01583
Device Sequence Number0
Product Code FOZ
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 06/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberAC0181250
Device Lot NumberREAX0791
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-