MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770500

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Angina (1710); Reaction (2414); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the site rite 8 base system emitted an electrical shock to the user and patient during use.Per the vat coordinator: "the user was performing a routine assessment on a patients right upper arm prior to a picc insertion.When assessing this arm the patient jumped and reported feeling a shock from the probe and the user felt a mild shock in the arm holding the probe that she thought may have been a strong static shock.Staff then moved to inspect the patient¿s left upper arm.Upon placing the probe to the skin on this arm the patient experienced a more intense electric shock that originated from the probe.The patient had an involuntary physical reaction to the shock that was witnessed by staff.Needless to say the patient was extremely unhappy about this happening and the procedure was postponed.The patient stated it felt like ¿electrocution¿ and shortly after reported having angina.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, 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 complaint of electrical shock during use of sr8 probe was unconfirmed because the reported issue could not be duplicated at the manufacture site.Visual inspection of the probe handle, nose area, and lens did not reveal any indicates of a high voltage spike from the probe.An electrical safety test was conducted on the device which included a patient leakage test.The results of the test indicated that patient leakage values from the device are within specification.Manufacturing records were reviewed and no potential contributing factors were found during manufacture and quality inspection of the device.The returned system did not display the behavior reported by the complainant and it is likely that the event was caused by another root cause.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

It was reported that the site rite 8 base system emitted an electrical shock to the user and patient during use.Per the vat coordinator: "the user was performing a routine assessment on a patients right upper arm prior to a picc insertion.When assessing this arm the patient jumped and reported feeling a shock from the probe and the user felt a mild shock in the arm holding the probe that she thought may have been a strong static shock.Staff then moved to inspect the patient¿s left upper arm.Upon placing the probe to the skin on this arm the patient experienced a more intense electric shock that originated from the probe.The patient had an involuntary physical reaction to the shock that was witnessed by staff.Needless to say the patient was extremely unhappy about this happening and the procedure was postponed.The patient stated it felt like ¿electrocution¿ and shortly after reported having angina.

• Brand Name: SITE-RITE 8 ULTRASOUND
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7191702
• MDR Text Key: 97502412
• Report Number: 3006260740-2017-02431
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741096891
• UDI-Public: (01)00801741096891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/29/2017,06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770500
• Device Catalogue Number: 9770500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2017
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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