• 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 Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of recv2613 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the accucath guidewire bent and came out of the casing when advancement was attempted.
 
Event Description
It was reported that the accucath guidewire bent and came out of the casing when advancement was attempted.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of difficulty advancing the guidewire was confirmed; however, the root cause was not identified. The product returned for evaluation was one 20 ga x 2. 25¿ accucath peripheral iv catheter assembly. The sample was received assembled with the catheter overlaying the needle shaft. The needle exhibited a bend at the exit site from the carrier. The guidewire did not protrude from the needle tip. The guidewire shaft protruded from the advancer slot and exhibited multiple bends. Following partial guidewire advancement, microscopic inspection of the distal end revealed the wire to be intact. Attempts to move the wire within the needle were successful; however resistance was experienced due to the bend in the needle shaft. The bends in the guidewire appeared to be caused by attempted guidewire advancement against resistance. The bend in the needle shaft appeared to be the cause of that resistance; however, the cause of the bend was not identified. Consequently this complaint is confirmed as ¿cause unknown¿ at this time. Potential contributing factors include storage conditions and device manipulation prior to or during attempted use. A lot history review (lhr) of recv2613 showed no other similar product complaint(s) from this lot number.
 
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
MDR Report Key8420251
MDR Text Key138942184
Report Number3006260740-2019-00566
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K153298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberAC0202250
Device Lot NumberRECV2613
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2019
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

-
-