MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE RITE 8 20MM CUE LINEAR PROBE (REFURBISHED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number N/A

Device Problems Break (1069); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  malfunction  

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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.

Event Description

It was reported by a tm - sheath for wire of the probe has been severed and is allowing the wire to be exposed.

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.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 the cord is pulling away at the strain relief was confirmed.The probe¿s cable sleeve is pulling out from the strain relief, no conductive wires were found to be exposed only shielding wires were found exposed.H3 other text : evaluation findings are in section h11.

Event Description

It was reported by a tm - sheath for wire of the probe has been severed and is allowing the wire to be exposed.

• Brand Name: SITE RITE 8 20MM CUE LINEAR PROBE (REFURBISHED)
• 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 Key: 18504611
• MDR Text Key: 333457414
• Report Number: 3006260740-2024-00072
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741155383
• UDI-Public: (01)00801741155383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9770603R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other