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 Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redt1694 showed five other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in finland.

Event Description

It was reported customer has insert powermidline on the patient and after a while there has been thrombosis symptoms and after ultrasounding they have found big thrombosis on the vein.

• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 9861160
• MDR Text Key: 184329101
• Report Number: 3006260740-2020-00965
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/28/2020
• 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