MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET FULL TRAY (; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redw1080 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported home health came to pt's house and picc would flush but not draw blood.It was stated the patient's shirt was wet so brought him to the hospital via the er on 6/16 and there was a hole identified in the catheter where the hub and extension leg meet.No other information was provided.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET FULL TRAY (
• 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: 10259008
• Report Number: 3006260740-2020-02393
• Device Sequence Number: 11491023
• Product Code: LJS
• UDI-Device Identifier: 00801741028564
• UDI-Public: (01)00801741028564
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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 Expiration Date: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 9173108
• Device Lot Number: REDW1080
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1