MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/25/2017
Type of Reportable Event	Malfunction
Additional 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 for evaluation.A lot history review (lhr) of rebt0256 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the picc was placed in the patient's right upper extremity and on (b)(6) 2017 was noted to be broken between the catheter and the hub.

• Brand Name: POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 7294465
• Report Number: 3006260740-2018-00288
• Device Sequence Number: 19289370
• Product Code: LJS
• UDI-Device Identifier: 00801741141751
• UDI-Public: (01)00801741141751
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Notification
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

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: CK000766
• Device Lot Number: REBT0256
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1