MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT SLIM MR, 8F,; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1618000

Device Problem Incomplete or Missing Packaging (2312)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No medical records have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.Medical images have been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.

Event Description

It was reported by the facility that the port they are currently purchasing is mri safe, however, the literature inside the port tray states the port is mri conditional.

Manufacturer Narrative

Photos were provided of the instructions/labeling material associated with the reported device and the evaluation.The alleged issue was that the labeling indicated the device was not mri safe, however, the information was unconfirmed and labeling does indicate the device is labeled as mri safe.Therefore, this event is no longer reportable.This supplemental is to provide the change in reportability.

Event Description

It was reported by the facility that the port they are currently purchasing is mri safe, however, the literature inside the port tray states the port is mri conditional.

• Brand Name: POWERPORT SLIM MR, 8F,
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7623387
• MDR Text Key: 111847686
• Report Number: 3006260740-2018-01461
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026485
• UDI-Public: (01)00801741026485
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 1618000
• Device Catalogue Number: 1618000
• Device Lot Number: REBY0755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1