MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC; CATHETER, INTRAVASCULAR, THERAPEUTIC LONG TERM

Catalog Number	3275335
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Picc line leaking from the lumen that was not in use for patient's continual milirinone infusion.Patient has had 4-5 picc lines placed with a shorter life span/dwell time than would be anticipated.Because of patient's heart, the tip is placed in the cavoatrial junction, which is equivalent to the svc.Insertion - ref - lot - expiration - udi - type.(b)(6) 2018 - 3274355 - recv0428 - 10/31/2020 - (b)(4) - double lumen.(b)(6) 2018 - 3274355 - reap1815 - 05/28/2019 - (b)(4)- double lumen.(b)(6) 2018 - 3275335 - rebx2428 - 09/30/2020 - (b)(4)- double lumen.(b)(6) 2017 - 3275335 - rebn0774 - 12/31/2019 - (b)(4) - double lumen.(b)(6) 2017 - 3275335 - rebw1247 - 08/31/2020 - (b)(4)- double lumen.(b)(6) 2017 - 3275335 - rebs1507 - 04/30/2020 - (b)(4)- double lumen.(b)(6) 2017 - 3274355 - rebr0723 - 05/31/2018 - (b)(4) - double lumen - initial picc line.Ref mfr report # 3006260740-2019-00642, 3006260740-2019-00648, 3006260740-2019-00646, 3006260740-2019-00647, 3006260740-2019-00644, 3006260740-2019-00645.

• Brand Name: POWERPICC
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC LONG TERM
• Manufacturer (Section D): BARD ACCESS SYSTEMS
• MDR Report Key: 8455949
• Report Number: MW5085172
• Device Sequence Number: 13560248
• Product Code: LJS
• UDI-Device Identifier: 00801741027949
• UDI-Public: (01)00801741027949
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 3275335
• Device Lot Number: REBX2428
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2019
• 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: Required Intervention
• Patient Age: 11 YR
• Patient Weight: 25