MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER PORT TI ISP, 8 FR. GROSHONG, INT W SP, SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8708560

Device Problems Component Incompatible (1108); Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported malfunction, the device was returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 8708560 port & catheter allegedly experienced suction problem, fluid leak, fracture, and incompatible component.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number was provided and a lot history review was performed.For the reported malfunction, the device was returned to bd for evaluation.The investigation was confirmed for compressive stress deformation and fracture.The root cause could not be determined.The device is labeled for single use.H10: g4; h6 (devicecode: 2170 suction issue, 2889 deformation due to compressive stress).H11: 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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 8708560 port & catheter allegedly experienced suction problem, fluid leak, fracture, and incompatible component.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.

• Brand Name: POWER PORT TI ISP, 8 FR. GROSHONG, INT W SP, SINGLE LUMEN
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9602432
• MDR Text Key: 192164263
• Report Number: 3006260740-2020-00221
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098918
• UDI-Public: (01)00801741098918
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8708560
• Device Lot Number: REDR2947
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/03/2020
• Patient Sequence Number: 1