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

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH ACE INTERMEDIATE KIT CATHETER (20G) 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
 

C.R. BARD, INC. (BASD) -3006260740 ACCUCATH ACE INTERMEDIATE KIT CATHETER (20G) CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2021
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling. Based on a review of this information, the following was concluded: the complaint of a damaged catheter was confirmed, but the exact cause could not be determined. One accucath ace was returned for investigation. The deployment system was received with the safety mechanism activated. The needle was fully retracted in the handle. The catheter was received over the section of guidewire that extended from the handle. The entire length of the catheter was crumpled, deformed, and curled over the guidewire. A microscopic examination of the catheter revealed the coiled tip of the guidewire was extending from the tip of the catheter. The catheter was removed from the guidewire. After removal, the catheter was stretched out and no portion of the tubing appeared to be missing. The coil at the distal end of the guidewire was deformed. The valve actuator was not engaged through the valve. Since the catheter was damaged and received over the wire, the complaint was confirmed. What caused the catheter to crumple could not be determined from the sample analysis and it is unknown if the damage occurred prior to or after the activation of the safety mechanism. A lot history review (lhr) of reey2691 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported "nurse and picc specialist were placing an accucath in a patient yesterday that needed a peripheral iv. I'm not sure exactly what happened but i believe there was a malfunction with the accucath. Nurse placed the accucath with no issue but when he pressed the button to retract the needle and remove the guide wire, it seemed to be caught somewhere on the catheter. The wire could not be removed from the catheter at all. It was a little difficult to remove the catheter also after we decided to terminate the iv. When we took it out, i inspected it and it looks like the curled part on the end of the guide wire seemed to be wrapped around the catheter tip. " 06/08/2021: the returned device was found kinked.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACCUCATH ACE INTERMEDIATE KIT CATHETER (20G)
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key12103654
MDR Text Key259640471
Report Number3006260740-2021-02550
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,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberAC1201252
Device Lot NumberREEY2691
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2020
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: 07/01/2021 Patient Sequence Number: 1
-
-