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

Model Number	0602870
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device for the malfunction has not been returned to the manufacturer for evaluation; however photos of the reported malfunction have been received.The investigation of the reported malfunction is currently underway.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 experienced a crack and a fluid leak.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a female whose weight and age were not provided.
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review will be performed.The device and photos have been returned for evaluation; the evaluation identified a leak and crack.Based upon the available information, 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0602870 implantable port allegedly experienced a crack and a fluid leak.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a female whose weight and age 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: 9592510
• Report Number: 3006260740-2020-00098
• Device Sequence Number: 374680
• 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,Followup
• Report Date (Section B): 04/02/2020

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: 0602870
• Device Catalogue Number: 0602870
• Device Lot Number: RECZ3412
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1