MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 6 SCANNER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number	9770066
Medical Device Problem Codes	Calibration Problem (2890); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 number (b)(4) showed no other similar complaint(s) from this serial number.
Event or Problem Description
It was reported by biomed on behalf of the hospitals risk management team that the sherlock 3cg failed to properly track the picc magnet when used with a site~rite 6 ultrasound causing a malpositioned picc.It was reported to biomed that the patient was a chronic a-fib patient and was not a proper candidate for 3cg or picc placement confirmed by ecg.The end user attempted to use the magnet tracking feature on sherlock and stated they could not get a proper reading.The rn felt that the catheter was not in the correct position, although the magnet tracking indication on the screen showed the picc down in the right atrium.After several stated attempts at repositioning the picc the rn decided to obtain a cxr and found that the catheter was up in the patients neck.The interventional radiologist was to correct the malposition the following day.Bas fa stated that the 3cg technology does not eliminate clinical judgment.The p-wave must be present, identifiable, and consistent, otherwise some other method of confirmation should be used and the clinician will want to make that determination.Information on slowing down the picc at a rate of 1cm/second as well as proper calibration techniques could help alleviate incorrect picc detection.Fa reached out to the sales rep and clinical specialist to follow-up for refresher training.

• Brand Name: SITE-RITE 6 SCANNER
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7912681
• Report Number: 3006260740-2018-02600
• Device Sequence Number: 9834249
• Product Code: IYO
• UDI-Device Identifier: 00801741091049
• UDI-Public: (01)00801741091049
• Combination Product (Y/N): N
• PMA/510(K) Number: K071204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9770066
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1