MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SM TI P.C. PORT W/INT.; IMPLANTABLE PORT

Model Number	0602190
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for the one malfunction.The company is still investigating the issue at this time.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 602190 implantable port allegedly experienced fluid leak.This information was received from one source.The event did not involve a patient as there was no patient contact.The patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
The lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.The investigation is confirmed for the fluid leak and material split, cut or torn issues.Based upon the available information, the definitive root cause for this event 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 602190 implantable port allegedly experienced fluid leak.This information was received from one source.The event did not involve a patient as there was no patient contact.The patient age, weight, and gender were not provided.

• Brand Name: SM TI P.C. PORT W/INT.
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9592513
• Report Number: 3006260740-2020-00096
• Device Sequence Number: 16257937
• Product Code: LJT
• UDI-Device Identifier: 00801741025549
• UDI-Public: (01)00801741025549
• 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): 06/25/2020

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: 0602190
• Device Catalogue Number: 0602190
• Device Lot Number: RECZ3388
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 06/25/2020
• Patient Sequence Number: 1