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

Catalog Number 1716000J

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for this malfunction is unknown, therefore the manufacturing review could not be conducted.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 171600j implanted powerport allegedly experienced frayed guidewire.This information was received from one source.This malfunction involved one patient with no consequences.The patient is (b)(6) year old male and weight was not provided.

Manufacturer Narrative

H10: the lot number for this malfunction is unknown, therefore the manufacturing review could not be conducted.The device was returned for evaluation and the investigation unconfirmed for reported malfunction.A definitive root cause could not be determined.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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 171600j implanted powerport allegedly experienced frayed guidewire.This information was received from one source.This malfunction involved one patient with no consequences.The patient is 65 year old male and weight was not provided.

• 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: 9596983
• MDR Text Key: 191482589
• Report Number: 3006260740-2020-00138
• 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: 06/29/2020

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 Catalogue Number: 1716000J
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/29/2020
• Patient Sequence Number: 1