MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. HARD BASE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F

Model Number	0605450
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation and photos were provided for review.Therefore, the investigation is confirmed for the reported deformation issue and identified fracture issue.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 0605450 implantable port allegedly experienced fracture and deformation due to compressive stress.The information was received from a single source.This malfunction did not involve a patient as there was no patient contact.Patients' age, weight and gender were not provided.

• Brand Name: M.R.I. HARD BASE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 11211147
• Report Number: 3006260740-2021-80003
• Device Sequence Number: 3719062
• Product Code: LJT
• UDI-Device Identifier: 00801741025945
• UDI-Public: (01)00801741025945
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

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
• Operator of Device: No Information
• Device Model Number: 0605450
• Device Catalogue Number: 0605450
• Device Lot Number: RECZ3433
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/21/2021
• Patient Sequence Number: 1