MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOME SUBQ PORT,HICKMAN W; IMPLANTABLE PORT

Model Number	0602870
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided and a lot history review was performed.The device was not returned for evaluation, therefore the investigation is inconclusive for the reported failure.The definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0602870 implantable port allegedly frayed material.This information was received from one source.One patient was involved and there was no reported patient injury.The patient is female and age and weight were not provided.

• Brand Name: DOME SUBQ PORT,HICKMAN W
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9205777
• Report Number: 3006260740-2019-03120
• Device Sequence Number: 2639398
• Product Code: LJT
• UDI-Device Identifier: 00801741025778
• UDI-Public: (01)00801741025778
• 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): 10/17/2019

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: 0602870
• Device Catalogue Number: 0602870
• Device Lot Number: RECW1211
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1