MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redp1137 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the 3cg wire broken during insertion of the picc.It was stated that 4cm of the wire had to be removed from the patient.On 07/16/2019- additional information from the facility stated, "initial stick was easy and uncomplicated, but then picc rn met resistance when advancing the catheter so picc rn stopped advancing, repositioned the patient, and attempted to advance again.When this was not possible, picc rn aborted the attempt.Picc rn commented since the last event, picc rn is very cautious and does not attempt to after unsuccessful picc insertion, the stylet which was preloaded in the catheter was found broken.A chest xray was performed and radiologist read "an interval new approximately 3-4 cm partially coiled wire projecting inferior to the tip of the left picc line, may represent retained wire." immediately, md were notified.The patient had to go to ir to have broken stylet removed".

• Brand Name: POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER
• 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: 8848896
• Report Number: 3006260740-2019-02236
• Device Sequence Number: 10842401
• Product Code: LJS
• UDI-Device Identifier: 00801741154904
• UDI-Public: (01)00801741154904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: S1295108FD2
• Device Lot Number: REDP1137
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention