MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPRT MRI ISP 8GR INT; IMPLANTABLE PORT

Model Number 9808560

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 returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 9808560.Implantable port allegedly experience device contamination with chemical or other material.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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 9808560.Implantable port allegedly experienced device contamination with chemical or other material.This report was received from a single source.This malfunction did not involve a patient.Age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number for the malfunction is unknown, therefore the manufacturing review could not be conducted.The device has been returned for evaluation; the evaluation was inconclusive for 2944 - device contamination with chemical or other material.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PPRT MRI ISP 8GR INT
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9602784
• MDR Text Key: 193306966
• Report Number: 3006260740-2020-00237
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/31/2020
• Patient Sequence Number: 1