• 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 SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

  • 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 SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2023
Event Type  malfunction  
Manufacturer Narrative
The information provided by bd 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 bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
 
Event Description
It was reported cord has come completely detached/exposing wiring.
 
Event Description
It was reported cord has come completely detached/exposing wiring.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The following were reviewed as part of this investigation: patient severity, 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 device was returned to the service facility for evaluation.During evaluation, the reported issue of cord has come completely detached/exposing wiring was confirmed.The probe cable is separating from the strain relief exposing shielding wires.The root cause is due to use of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer Contact
becky garcia
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key17062770
MDR Text Key316865549
Report Number3006260740-2023-02259
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741138218
UDI-Public(01)00801741138218
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number9770603
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/23/2023
Initial Date FDA Received06/05/2023
Supplement Dates Manufacturer Received06/15/2023
Supplement Dates FDA Received06/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
-
-