MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VACCESS CT LP PRTP 6F; IMPLANTABLE PORT

Model Number 7360001

Device Problem Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

For the reported information, the devices were not returned to bd for evaluation.However, one malfunction provided a photo for review.The company is still investigating the issue at this time.The devices are labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model 7360001 implantable port allegedly experienced material frayed.This information was received from various sources.The malfunctions did not involve a patient.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model 7360001 implantable port allegedly experienced material frayed.This information was received from various sources.The malfunctions did not involve a patient.Patient age, gender, and weight were not provided.

Manufacturer Narrative

H10: a lot history review was performed as a lot number was provided.For the reported information, the devices were not returned to bd for evaluation.However, one malfunction provided a photo for review.Both investigations were inconclusive for material frayed as no sample was returned for evaluation and the photo provided did not confirm material frayed.Based on the information provided, the definitive root cause is unknown.The devices are labeled for single use.H10: g4 h11: b5, h6(results, 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.

• Brand Name: VACCESS CT LP PRTP 6F
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9211266
• MDR Text Key: 164291357
• Report Number: 3006260740-2019-03205
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027444
• UDI-Public: (01)00801741027444
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7360001
• Device Catalogue Number: 7360001
• Device Lot Number: REDP2249
• Date Manufacturer Received: 12/31/2019
• Patient Sequence Number: 1