MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP ALTERNATIVE BUMPLS, 8F CHRONOFLEX, W SP; IMPLANTABLE PORT

Model Number 4808060

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that some time post port implant, the patient allegedly experienced allergic reaction, fibrin sheath and blood clot were formed due to heparin reaction.Therefore, the patient received prescribed medication.Reportedly, the device was replaced.Patient status is unknown.

• Brand Name: POWERPORT MRI ISP ALTERNATIVE BUMPLS, 8F CHRONOFLEX, W SP
• 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: 9857807
• MDR Text Key: 184754654
• Report Number: 3006260740-2020-00929
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027321
• UDI-Public: (01)00801741027321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4808060
• Device Catalogue Number: 4808060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• 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): Other; Required Intervention