MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE SLIM 8FR; IMPLANTABLE PORT

Model Number 1618000

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

Patient Problems Erosion (1750); Local Reaction (2035)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was provided, a manufacturing review was not required to be performed.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged reaction post port implant(skin erosion) issue due to the fact that no sample was returned for evaluation.The definitive root cause could not be determined.(expiration date: 11/2020).

Event Description

It was reported that post port device implant, the patient developed blistering and skin erosion at the port site.The patient status is unknown.

• Brand Name: POWERPORT CLEARVUE SLIM 8FR
• Type of Device: IMPLANTABLE PORT
• 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.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9648407
• MDR Text Key: 177009246
• Report Number: 3006260740-2020-00304
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026485
• UDI-Public: (01)00801741026485
• Combination Product (y/n): N
• PMA/PMN Number: K122899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1618000
• Device Catalogue Number: 1618000
• Device Lot Number: REDT4349
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Other