MAUDE Adverse Event Report: BARD ACCESS SYSTEMS XPORT ISP MRI 9.6FR; IMPLANTABLE PORT

Model Number	0607555
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided, a manufacturing review was performed.The devices were returned to bd and are pending 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 0607555 port allegedly fractured.This information was received from one source.This malfunction did not involved patient with no known impact to the patient.The patient's age, sex and weight were unknown.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0607555 implantable port allegedly experienced a fracture.This information was received from one source.This malfunction did not involved patient with no known impact to the patient.The patient's age, sex and weight were unknown.
Additional Manufacturer Narrative
H10: the lot no for the device was provided, therefore a lot history review was performed.The sample was returned to the manufacturer for evaluation.A photo was provided for review.The investigation is inconclusive for the reported broken tip.The definitive root cause is unknown.The device is 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.

• Brand Name: XPORT ISP MRI 9.6FR
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10283667
• Report Number: 3006260740-2020-02465
• Device Sequence Number: 2679063
• Product Code: LJT
• UDI-Device Identifier: 00801741026201
• UDI-Public: (01)00801741026201
• 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): 10/13/2020

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: 0607555
• Device Catalogue Number: 0607555
• Device Lot Number: REEN3555
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1