MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP, 8 FR GROSHONG, INTER. W SUTURE PLUG, S/L; IMPLANTABLE PORT

Model Number 1808560

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, lot number was provided, and lot history review.The sample was not returned for evaluation.Three electronic photos were provided for review.The investigation is confirmed for foreign material in the package.A root cause has not been determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 1808560.Implantable port was allegedly experienced foreign material in package.This report was received from a single source.This event did not involve patient with no patient contact.Age, weight, and gender were not provided for the patient.

• Brand Name: POWERPORT MRI ISP, 8 FR GROSHONG, INTER. W SUTURE PLUG, S/L
• 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: 9599219
• MDR Text Key: 190785981
• Report Number: 3006260740-2020-00193
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027116
• UDI-Public: (01)00801741027116
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REDV4135
• Date Manufacturer Received: 12/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1