MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL; IMPLANTABLE PORT

Catalog Number 8808560

Device Problems Component Incompatible (1108); Stretched (1601); Unraveled Material (1664); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history reviewed was performed.The sample was not returned to the manufacturer for inspection/evaluation however, three electronic photos were provided.Upon investigation guidewire elongation/unraveling were identified therefore, the alleged malfunction was confirmed.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 8808560 implantable port allegedly experienced incompatible component, stretched material, and unraveled material.This information was received from one source.Of the one malfunction, one patient was involved with no patient consequence or impact.The weight of the 61 year old female patient was not provided.

Manufacturer Narrative

H10: as the lot number for the device was provided, a lot history reviewed was performed.The sample was returned to the manufacturer for inspection/evaluation and three electronic photos were provided for review.The investigation was confirmed for guidewire elongation/unraveling, as the photo review identified elongation of the outer wrapping wire and unraveling/separation of the outer wrapping wire and inner core wire.Based upon the available information, the definitive root cause for this event was unknown.The device was 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 8808560 implantable port allegedly experienced incompatible component, stretched material, and unraveled material.This information was received from one source.The patient was involved with no patient consequence or impact.The weight of the 61 years old female patient was not provided.

Manufacturer Narrative

H10: as the lot number for the device was provided, a lot history reviewed was performed.The sample was returned to the manufacturer for inspection/evaluation and three electronic photos were provided for review.The investigation was confirmed for difficult to advance and stretched.Based upon the available information, the definitive root cause for this event was unknown.The device was labeled for single use.H10: g4.H11: b5, h6 (device, method).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 8808560 implantable port allegedly experienced stretched material and difficult to advance.This information was received from one source.The patient was involved with no patient consequence or impact.The weight of the 61 years old female patient was not provided.

• Brand Name: POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, 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: 10280588
• MDR Text Key: 199129703
• Report Number: 3006260740-2020-02453
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098994
• UDI-Public: (01)00801741098994
• 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: 01/14/2021

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: 8808560
• Device Lot Number: RECX1910
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 09/30/2020; 12/31/2020
• Supplement Dates FDA Received: 10/20/2020; 01/14/2021
• Patient Sequence Number: 1