MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER, 5F DL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recz3288 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recz3288) have been reported from the same facility.
Event or Problem Description
It was reported that the rn trimmed the picc at 40 cm and when placing the picc she saw the sherlock stylet icon go downward but never saw and changes with the p-wave.It was stated the rn attempted some troubleshooting but saw no changes in the p-wave.Rn said she second guessed her measurements so called for another picc kit.The rn left some additional length on the new picc used and while placing the picc "immediately saw changes in the p-wave as she advanced the catheter." the second picc was placed successfully.Another rn stated she too had "a similar experience recently" with the same lot.This report addresses the second event that was "similar" to the first with no further details.

• Brand Name: POWERPICC SOLO CATHETER, 5F DL, 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8961291
• Report Number: 3006260740-2019-02597
• Device Sequence Number: 16796674
• Product Code: LJS
• UDI-Device Identifier: 00801741137631
• UDI-Public: (01)00801741137631
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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 Model Number: N/A
• Device Catalogue Number: CK000590A
• Device Lot Number: RECZ3288
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1