MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Type  Injury  

Event Description

It was reported that a powermidline was inserted in a patient on (b)(6) 2020 by an anesthesiologist.This is the 2nd powermidline the patient has had for her current treatment (1st powermidline addressed in fda report 3006260740-2020-01111) and was retracted 5cm on (b)(6) 2020 because it was "too deep".The patient had been receiving cefuroxime and vancomycin through the midline to treat an endoprosthesis infection.The patient had also been receiving enoxaparin injections prior to the thrombus development for prophylaxis.The powermidline was removed on (b)(6) 2020 due to new thrombus formation.Treatment continued via piv because the patient refused a 3rd picc/midline insertion.

• Brand Name: BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 9916122
• MDR Text Key: 186605875
• Report Number: 3006260740-2020-01134
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741141034
• UDI-Public: (01)00801741141034
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: P6154118
• Device Lot Number: REDT1694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR