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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT; 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 03/08/2023
Event Type  malfunction  
Manufacturer Narrative
H11: 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 the information, the following was concluded: the device was returned to service facility for evaluation.During evaluation, the reported issue of cord is pulling away at the strain relief was confirmed.The probe cable is separating from the strain relief which is exposing wires.The root cause is due to use of the device.H3: evaluation findings are in section h11.
 
Event Description
It was reported the cable is damaged at the end of the strain relief.(b)(6) 2023 it was found during an investigation the probe cable is separating from the strain relief which is exposing wires.
 
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Brand Name
SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT
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)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
becky garcia
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key17190234
MDR Text Key317771249
Report Number3006260740-2023-02595
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741138324
UDI-Public(01)00801741138324
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
Report Date 06/16/2023
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 Number9770602
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/16/2023
Initial Date FDA Received06/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2019
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;
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