MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-LUMEN); 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	11/07/2019
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 redq1548 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported 5 fr triple lumen powerpicc was placed in the left upper arm, basilic vein, 4 cm external length; securacath in place.It was stated that the dressing was noted to be moist, and when the line was flushed, leaking was noted from the catheter near the base of the securacath.The catheter was emergently exchanged as multiple vasopressors were infusing through the picc.The new picc was secured using a statlock.

• Brand Name: POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-LUMEN)
• 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: 9417276
• Report Number: 3006260740-2019-03759
• Device Sequence Number: 11193675
• Product Code: LJS
• UDI-Device Identifier: 00801741028168
• UDI-Public: (01)00801741028168
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: 3385108Q
• Device Lot Number: REDQ1548
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 75