MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TITANIUM DOME IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F

Model Number	0602870
Medical Device Problem Codes	Suction Problem (2170); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for the reported malfunction; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported reflow issue is inconclusive.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 indicates that model 0602870 implanted port allegedly experienced obstruction of flow.The information was received from one source.One patient was involved with no reported patient injury.Age, gender and weight were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 0602870 implanted port allegedly experienced suction issue.The information was received from one source.One patient was involved with no reported patient injury.Age, gender and weight were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the reported malfunction; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported suction issue is inconclusive.Based upon the available information, the definitive root cause for this event 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.

• Brand Name: TITANIUM DOME IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10286303
• Report Number: 3006260740-2020-02487
• Device Sequence Number: 14097587
• 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): 10/19/2020

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: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/19/2020
• Patient Sequence Number: 1