MAUDE Adverse Event Report: BARD ACCESS SYSTEMS L/P TI CHRFX ATT 6FR DAI; SLIM PORT TITANUM IMPLANTABLE PORT

Model Number	0605550
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation; therefore, the investigation is inconclusive for the fluid leak as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model 0605550 implanted port allegedly experienced a fluid leak.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.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 (1) malfunction.A review of the reported information indicated that model 0605550 implanted port allegedly experienced a fluid leak.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: for the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was returned for evaluation.After further evaluation, the investigation is unconfirmed for the alleged leaking catheter issue.The definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: b5, h6 (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 (1) malfunction.A review of the reported information indicated that model 0605550 implanted port allegedly experienced a fluid leak.This information was received from one source.The malfunction involved a patient with no patient consequences.The patient¿s age, weight, and gender were not provided.

• Brand Name: L/P TI CHRFX ATT 6FR DAI
• Common Device Name: SLIM PORT TITANUM IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8819799
• Report Number: 3006260740-2019-02150
• Device Sequence Number: 14162870
• Product Code: LJT
• UDI-Device Identifier: 00801741025976
• UDI-Public: (01)00801741025976
• 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,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: 0605550
• Device Catalogue Number: 0605550
• Device Lot Number: RECX3847
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 12/31/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/10/2019; 01/07/2020
• Patient Sequence Number: 1