MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F

Model Number	1829570
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
As the lot number for the device was provided, a lot history review will be performed.The sample was not returned to the manufacturer for evaluation; therefore, the investigation is inconclusive for obstruction of flow.A definitive root cause for the reported event could not be determined.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 1829570 implantable port allegedly experienced obstruction of flow.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; therefore, the investigation is inconclusive for the reported obstruction of flow and suction issue.A definitive root cause for the reported event could not be determined.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 1829570 implantable port allegedly experienced obstruction of flow and suction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.Female patients' age and weight were not provided.

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10742581
• Report Number: 3006260740-2020-03499
• Device Sequence Number: 3486303
• Product Code: LJT
• UDI-Device Identifier: 00801741027192
• UDI-Public: (01)00801741027192
• 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): 01/07/2021

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: 1829570
• Device Catalogue Number: 1829570
• Device Lot Number: RECQ2037
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1