MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; LONG TERM INTRAVASCULAR CATHETER

Model Number 1295108FD

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2017

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebv1551 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that they are having an issue with the ecg wandering upward and off the screen of the site rite 8.They stated that after switching the ultrasound to the sherlock and calibrating it, the yellow (internal) ecg goes up and off the screen, so they are unable to use it.They stated that they have changed the settings to try and fix it, but nothing has worked.They state the yellow line never comes back on the screen despite troubleshooting.This happened during placement of the device and a new dl picc was placed.A chest x-ray was obtained due to the inability to visualize the internal lead.No reported patient injury.

Manufacturer Narrative

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 powerpicc or the 3cg stylet caused or contributed to the reported event was inconclusive due to the sample condition.It was reported that the yellow (intravascular) line goes up and off the screen and never returns.One scanned image of the sherlock 3cg tcs graph was provided for investigation.The date of (b)(6) 2017 was on the document.The waveform was only visible on the external (or baseline) ecg line.No waveform was visible on the intravascular ecg line.What caused the reported event was unknown and since the powerpicc and 3cg stylet were not returned, the root cause was inconclusive.A lot history review (lhr) of rebv1551 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the facility that they are having an issue with the ecg wandering upward and off the screen of the site rite 8.They stated that after switching the ultrasound to the sherlock and calibrating it, the yellow (internal) ecg goes up and off the screen, so they are unable to use it.They stated that they have changed the settings to try and fix it, but nothing has worked.They state the yellow line never comes back on the screen despite troubleshooting.This happened during placement of the device and a new dl picc was placed.A chest x-ray was obtained due to the inability to visualize the internal lead.No reported patient injury.

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• Type of Device: LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 7143632
• MDR Text Key: 95828928
• Report Number: 3006260740-2017-02306
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 1295108FD
• Device Catalogue Number: 1295108FD
• Device Lot Number: REBV1551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1