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 Inadequate Instructions for Healthcare Professional (1319); Component Missing (2306); Illegible Information (4050); Missing Information (4053)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.However, photo was provided for evaluation.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 8708560 port allegedly experienced missing component.The information was received from a single source.This malfunction involved a patient with no consequences.Age, weight and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 8708560 port allegedly experienced missing component.The information was received from a single source.This malfunction involved a patient with no consequences.Age, weight and gender were not provided.

Manufacturer Narrative

H10: the lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.However,a photo was provided for review.The company is still investigating the issue at this time.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 indicates that model 8708560 port allegedly experienced illegible information, missing information and inadequate information.The information was received from a single source.This malfunction involved a patient with no consequences.Age, weight and gender were not provided.

Manufacturer Narrative

H10: the lot number was provided for the reported malfunction; therefore, a lot history was performed.The sample was not returned to the manufacturer for inspection/evaluation; therefore, the investigating is inconclusive for illegible information, missing information and inadequate information.Based upon the available information, the definitive root cause is unknown.The devices are 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.

• 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: 10289943
• MDR Text Key: 199286136
• Report Number: 3006260740-2020-02542
• 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,Followup
• Report Date: 01/11/2021

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: REDS3790
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 09/30/2020; 12/31/2020
• Supplement Dates FDA Received: 10/14/2020; 01/11/2021
• Patient Sequence Number: 1