MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPRT MRI ISP 6CF BAS; POWERPORT MRI

Catalog Number 8816002

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the devices were provided, a lot history review was performed.Three samples were returned to the manufacturer for evaluation.The company is still investigating the issue at this time.

Event Description

This report summarizes three malfunction.A review of the malfunctions indicated that model 8816002 powerport mri reportedly experienced component missing.This report was received from various source.All three malfunctions did not involve a patient as there was no patient contact.The age, sex and weight of the patient were not provided.

Manufacturer Narrative

H10: as the lot number for the devices were provided, a lot history review was performed.Three samples were returned to the manufacturer for evaluation.However, for two samples product brochures alone were received in the box and for the remaining sample the complete product was not returned.Therefore, the investigation is inconclusive for the reported component missing.Based upon the available information, the definitive root cause for this event 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.

Event Description

This report summarizes three malfunction.A review of the malfunctions indicated that model 8816002 powerport mri reportedly experienced component missing.This report was received from various source.All three malfunctions did not involve a patient as there was no patient contact.The age, sex and weight of the patient were not provided.

• Brand Name: PPRT MRI ISP 6CF BAS
• Type of Device: POWERPORT MRI
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10749695
• MDR Text Key: 213948334
• Report Number: 3006260740-2020-03540
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741099014
• UDI-Public: (01)00801741099014
• 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: 01/05/2021

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: 8816002
• Device Lot Number: REDX5065
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 01/05/2021
• Patient Sequence Number: 1