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 Fracture (1260); Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported malfunction, the device and a photo were provided for review.The company is still investigating the issue at this time.The catalog number identified has not been cleared in the us, but is similar to the powerport mri isp products that are cleared in the us.The pro code for the powerport mri isp products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 8808560 implantable port allegedly experienced a fracture.This information was provided from a single source.One patient was involved with no reported patient injury.The patient's age, weight, and gender were not provided.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport mri isp products that are cleared in the us.The pro code for the powerport mri isp products is identified in d2.H10: the lot number was provided for this malfunction; therefore, a lot history review was performed.Device was returned for evaluation, and images were provided for review.The investigation of the device confirmed for he alleged break as well as the misassembly of the cath-lock.Based on the available information, a definitive root cause could not be determined.The device is labeled for single use.H10: g4 h11: b5, h6 (result, 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 8808560 implantable port allegedly experienced a fracture and was misassembled during installation.This information was provided from a single source.One patient was involved with no reported patient injury.The patient's age, weight, and gender were 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: 10261224
• MDR Text Key: 198721361
• Report Number: 3006260740-2020-02404
• 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
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: REDS3794
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1