MAUDE Adverse Event Report: BARD ACCESS SYSTEMS XPORT W/6 FR CHRONOFLEX CATHETER; IMPLANTABLE PORT

Model Number	0605850
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0605850, implantable port, was allegedly fractured during tunneling.This information was received from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: for the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.After further evaluation, the investigation confirmed for the alleged catheter tip damage during tunneling issue.The definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: h6 (method, 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 0605850, implantable port, was allegedly fractured during tunneling.This information was received from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.

• Brand Name: XPORT W/6 FR CHRONOFLEX CATHETER
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9208950
• Report Number: 3006260740-2019-03138
• Device Sequence Number: 16255181
• Product Code: LJT
• UDI-Device Identifier: 00801741026010
• UDI-Public: (01)00801741026010
• 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): 01/07/2020

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: 0605850
• Device Catalogue Number: 0605850
• Device Lot Number: REYG1072
• 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: 01/07/2020
• Patient Sequence Number: 1