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	08/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bd 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 bd.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redv2044 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported: "8/22 @ 0756, dressing changed due to leaking and lifting up along the side.8/22 @ 1300, vascular access team called to assess picc due to persistent leaking; leaking was noted from the insertion site, catheter slowly pulled back with flushing and fracture noted a few centimeters down on the internal segment of the catheter." "placement info: 5 fr triple lumen provena powerpicc placed in the right upper arm, brachial vein.12 cm external length; securacath in place" no pt harm reported.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.Initial medwatch was submitted as a second event, upon further information it was found that this reported is a cascading event of medwatch report submitted under report number 3006260740-2020-03356.
Event or Problem Description
It was reported: "8/22 @ 0756, dressing changed due to leaking and lifting up along the side.8/22 @ 1300, vascular access team called to assess picc due to persistent leaking; leaking was noted from the insertion site, catheter slowly pulled back with flushing and fracture noted a few centimeters down on the internal segment of the catheter." "placement info: 5 fr triple lumen provena powerpicc placed in the right upper arm, brachial vein.12 cm external length; securacath in place" no pt harm reported.

• 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: 10583563
• Report Number: 3006260740-2020-03358
• Device Sequence Number: 2822769
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 3385108Q
• Device Lot Number: REDV2044
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 104