MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TI POWERPORT LOW PROFILE - JAPAN ONLY; IMPLANTABLE PORT

Catalog Number 1716000J

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided; therefore, a lot history review is currently being performed.The device was returned to the manufacturer for evaluation.A photo was also provided.The company is still investigating the issue at this time.The device is labeled for single use.The catalog number identified in section has not been cleared in the us, but is similar to the ti powerport low profile products that are cleared in the us.The pro code for the ti powerport low profile products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 1716000j implantable port allegedly experienced device contamination with chemical or other material.This information was received from one source.This event did not involve a patient as there was no patient contact.

Manufacturer Narrative

H10: the lot number was provided; therefore, a lot history review was performed.The sample was returned and the investigation identified device contamination with foreign material.A definite root cause for the reported event could not be determined.The device was 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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 1716000j implantable port allegedly experienced device contamination with chemical or other material.This information was received from one source.This event did not involve a patient as there was no patient contact.

• Brand Name: TI POWERPORT LOW PROFILE - JAPAN ONLY
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9970547
• MDR Text Key: 196234054
• Report Number: 3006260740-2020-01376
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111631
• UDI-Public: (01)00801741111631
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1716000J
• Device Lot Number: REDP4668
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/08/2020
• Patient Sequence Number: 1