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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Fistula (1862); Swelling (2091); Vascular Dissection (3160)

Event Type  Injury  

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 for evaluation.A history review of serial (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

It was reported by the iv resource rn that on (b)(6) 2018 a malposition arterial picc placement occurred when using a site rite 8 ultrasound and sherlock 3cg on a quadriplegic patient in a normal (non icu) medical environment.The rn reported a basilic placement with a 4 fr.Small vessel catheter, however, follow-up showed a brachial artery placement.Swelling to the patients extremity revealed the picc malposition when doppler confirmed abnormal blood flow.The picc was removed (b)(6) 2018 and the patient was discharged.On (b)(6) 2018 patient follow-up with vascular ultrasound showed 75% arterial dissection and fistula.The incidence was stated to occur because there was no apparent indicators that the placement was arterial.The patients p-wave showed no negative deflection; the end user didn't notice anything concerning or indicative of a malpositioned picc.Fa recommendations included reviewing pre-scan with team emphasizing the importance of identifying all vasculature structures prior to the beginning of the procedure as well as other identifying features of a arterial picc placement.Facility stated additional information will be provided upon completion of an internal investigation.

• 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.; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7571125
• MDR Text Key: 110179181
• Report Number: 3006260740-2018-01222
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098338
• UDI-Public: (01)00801741098338
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9770501
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention