MAUDE Adverse Event Report: BARD ACCESS SYSTEMS XPORT ISP MRI 8 FR GROSH W/MI; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	7757540
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 7757540 port & catheter allegedly had a defective component.This report was received from a single source.This event did not involve patient with no patient contact.The patients age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: one sample was returned for the reported malfunction.The lot number was provided and lot history review was performed.The device evaluation identified the distal segment of the vessel dilator slightly curved and belled open with the tip evidencing deformation.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4 h11: b5, h6(results, 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 or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 7757540 port & catheter allegedly had a defective component.This report was received from a single source.This malfunction did not involve patient as there was no patient contact.The patients age, weight and gender were not provided.

• Brand Name: XPORT ISP MRI 8 FR GROSH W/MI
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9211278
• Report Number: 3006260740-2019-03208
• Device Sequence Number: 11550005
• Product Code: LJT
• UDI-Device Identifier: 00801741027505
• UDI-Public: (01)00801741027505
• 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,Followup
• Report Date (Section B): 01/08/2020

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: 7757540
• Device Catalogue Number: 7757540
• Device Lot Number: RECP0214
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1