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

Model Number 9770501

Device Problems Display or Visual Feedback Problem (1184); 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 device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

End users reported they feel the sr8 displays incorrect ekg, failure to obtain ekg, and no negative deflection leading to picc malposition(s).Details on a recent placement were provided as follows: left basilic.Trim at 51cm.Sherlock places correctly.Red/black leads correct.Rn placed picc sherlock did not trace smoothly.Rn pulled wire, re-calibrated, re-advanced wire.Looked better.Placed to hub.Saw inverted p-waves.Pulled back 1cm to ¿0¿.Biphasic p-waves pulled back to ¿1¿cm.Biphasic pulled back to ¿2¿cm.Neg deflection- pb- ¿3¿cm.Neg deflection- pb- ¿4¿cm.Slight neg - pb - ¿5¿cm.No negative deflection and tall p-waves at 5cm ext.Pb to ¿6¿cm.P-w smaller.Final position ¿5¿cm ext.Printed.P-cxr ordered.Patient sat up at about 40 degrees in bed for p-cxr.Radiologist read picc tip as ¿in the svc¿.Stated that pt appeared rotated on cxr.Not a great xr but tip appears to be significantly above the caj.Clinical specialist, was beside for placement and witnessed placement.Vat rn was comfortable with a rad reading of svc and pt was discharged home.No know harm to patient or anyone else r/t event.

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 following were reviewed as part of this investigation: patient severity, 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 device was returned to the service facility for evaluation.During evaluation, the reported issue of sr8 displays incorrect ekg, failure to obtain ekg, and no negative deflection leading to picc malposition was unconfirmed.During evaluation the scanner was tested with a sherlock to test the fixture on interactive demo and there was no problem with the ekg.No other functionality issues with the equipment were found during evaluation/servicing.A history review of serial number (b)(6) showed no other similar complaint(s) from this serial number.

Event Description

End users reported they feel the sr8 displays incorrect ekg, failure to obtain ekg, and no negative deflection leading to picc malposition(s).Details on a recent placement were provided as follows: left basilic trim at 51cm sherlock places correctly red/black leads correct rn placed picc sherlock did not trace smoothly.Rn pulled wire, re-calibrated, re-advanced wire.Looked better.Placed to hub.Saw inverted p-waves pulled back 1cm to ¿0¿ biphasic p-waves pulled back to ¿1¿cm biphasic pulled back to ¿2¿cm neg deflection- pb- ¿3¿cm neg deflection- pb- ¿4¿cm slight neg - pb - ¿5¿cm no negative deflection and tall p-waves at 5cm ext pb to ¿6¿cm.P-w smaller final position ¿5¿cm ext.Printed.P-cxr ordered.Patient sat up at about 40 degrees in bed for p-cxr.Radiologist read picc tip as ¿in the svc¿.Stated that pt appeared rotated on cxr.Not a great xr but tip appears to be significantly above the caj.Clinical specialist, was beside for placement and witnessed placement.Vat rn was comfortable with a rad reading of svc and pt was discharged home.No know harm to patient or anyone else r/t event.

• 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
• MDR Report Key: 7563247
• MDR Text Key: 109980606
• Report Number: 3006260740-2018-01203
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098338
• UDI-Public: (01)00801741098338
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770501
• Device Catalogue Number: 9770501
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1