MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA TLS 5F TL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S9395108D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned for evaluation.
Event or Problem Description
It was reported after customer gained access with needle, they were able to thread the wire and then introducer with no issues, however they went to thread picc and met resistance.Nurse manipulated the picc back and forth a few times to see if the picc would pass resistance but it did not.After not being able to thread the picc he then removed the device and when to flush the line with the sty-let still in device, at that point he saw a piece of the sty-let come out of the picc that had broken off.

• Brand Name: POWERPICC PROVENA TLS 5F TL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10993396
• Report Number: 3006260740-2020-20877
• Device Sequence Number: 4396507
• Product Code: LJS
• UDI-Device Identifier: 00801741112911
• UDI-Public: (01)00801741112911
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: S9395108D
• Device Catalogue Number: S9395108D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/11/2020
• 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: Other