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 Problem No Known Impact Or Consequence To Patient (2692)

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 following were reviewed as part of this investigation: patient severity, frequency 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 that the picc was placed too deep was inconclusive due to the nature of the complaint and from the radiographic image that was provided for investigation.The image showed a thoracic region with what appeared to be various wires.Two extension lines, a dimension line, and text, which read 77.88mm, was superimposed over the radiographic image.The object being measured between the two short extension lines and parallel to the longer dimension line was indiscernible.The position of the picc was also indiscernible.It was reported that the ecg signal was used during placement.The sherlock 3cg tcs displays an ecg signal detected by the intravascular and body electrodes, which can be used for catheter tip positioning.In patients with a distinct p-wave, the p-wave will increase in amplitude as the catheter approaches the tip of the cavo-atrial junction.As the catheter advances into the right atrium, the p-wave will decrease in amplitude and may be biphasic or invert.Do not rely on ecg signal detection for catheter tip positioning when interpretation of the external or intravascular ecg p-wave is difficult.For example, when p-wave is not present, p-wave is not identifiable, p-wave is intermittent.These conditions may be a result of heart rhythm abnormalities, atrial fibrillation, atrial flutter, severe tachycardia or presence of cardiac rhythm devices.In these cases, rely on magnetic navigation and external measurement for tip positioning and use chest x-ray or fluoroscopy to confirm catheter tip location, as indicated by institutional guidelines and clinical judgment.Another potential contributing factor is the stylet tip position.The ifu states, ¿prior to insertion, ensure that the stylet tip is contained inside and within the catheter but not more than 1cm from the trimmed end of the catheter.¿ it was unknown if any complications associated with the clinical setting affected the functional performance of the device.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

The facility reported a picc malposition.It was stated that when using the sr 8 w/gt technology , the healthcare professional has had multiple issues where the picc is placed 3-4 cm too deep.Customer stated the readings are placed too deep based on the ecg signal.No other information was reported.

• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6623657
• MDR Text Key: 77297718
• Report Number: 3006260740-2017-00740
• 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: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• 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: 9770501
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1