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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC
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C.R. BARD, INC. (BASD) -3006260740 SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number N/A
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2023
Event Type  malfunction  
Event Description
It was reported after insertion of the needle, the guide wire was passed.When attempting to remove it, the guide failed (broken).No other information was provided.
 
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 device has not been returned to the manufacturer for evaluation.
 
Event Description
It was reported after insertion of the needle, the guide wire was passed.When attempting to remove it, the guide failed (broken).No other information was provided.
 
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.Initial medwatch report was submitted, upon further review it was found that this medwatch report 3006260740-2023-05648 is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2023-05645.
 
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Brand Name
SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)
Type of Device
TRANSDUCER, ULTRASONIC, DIAGNOSTIC
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
maddy vincent
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key18311957
MDR Text Key330293184
Report Number3006260740-2023-05648
Device Sequence Number1
Product Code ITX
UDI-Device Identifier00801741037771
UDI-Public(01)00801741037771
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K042445
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number900013B01
Device Lot NumberREGY0690
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age80 YR
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