MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT TI L/P 6 CHRONOFLEX W/SUTURE PLUGS ATTACHABLE SL; IMPLANTABLE PORT

Catalog Number 8716000

Device Problem Nonstandard Device (1420)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

For the reported information, the device was not returned to bd for evaluation.However, a photo was provided for review.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 powerport ti l/p 6 chronoflex w/suture plugs attachable sl products that are cleared in the us.The pro code for the powerport ti l/p 6 chronoflex w/suture plugs attachable sl products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 8716000 implantable port allegedly experienced a nonstandard device.This information was received from one source.The malfunction did not involve a patient.Therefore, the patient¿s age, weight, and gender were not provided.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport ti l/p 6 chronoflex w/suture plugs attachable sl products that are cleared in the us.The pro code for the powerport ti l/p 6 chronoflex w/suture plugs attachable sl products is identified in d2.H10: as the lot number for the device was provided, a lot history review was performed.The device was not returned to bd for evaluation.However, a photo was provided for review.The investigating is inconclusive for nonstandard device.A definitive root cause could not be determined.The device is labeled for single use.H10: g4.H11: g1, h6(results and conclusion).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 8716000 implantable port allegedly experienced a nonstandard device.This information was received from one source.The malfunction did not involve a patient.Therefore, the patient¿s age, weight, and gender were not provided.

• Brand Name: POWERPORT TI L/P 6 CHRONOFLEX W/SUTURE PLUGS ATTACHABLE SL
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9965225
• MDR Text Key: 198517788
• Report Number: 3006260740-2020-01323
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098932
• UDI-Public: (01)00801741098932
• 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: 10/07/2020

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: 8716000
• Device Lot Number: REDS4756
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/07/2020
• Patient Sequence Number: 1