MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. DUAL-LUMEN IMPLANTABLE PORT, LEONARD, 10F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0607200
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Of the reported two malfunctions, lot number were provided for one malfunction and the lot history review was performed.The product catalog number for one malfunction was reported as unk power port duo.For both the malfunctions the samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation is inconclusive for the reported obstruction of flow.Based on the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicates that model 0607200 port & catheter, implanted, subcutaneous, intravascular allegedly experienced obstruction of flow.These information's were received from a various sources.Both the malfunctions involved patient with no patient consequences.For both the malfunctions patients' age, weight and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 0607200 port & catheter, implanted, subcutaneous, intravascular allegedly experienced obstruction of flow.These information was received from a single sources.This malfunction involved one patient with no patient consequences.Patients' age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: for the reported two malfunctions, reportability was reassessed and determined to be no longer reportable for one malfunction.H10: of the reported one malfunction, lot number was provided and the lot history review was performed.Sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation is inconclusive for the reported obstruction of flow.Based on the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.H10: g4.H11: b5, d4(corporate lot no).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: M.R.I. DUAL-LUMEN IMPLANTABLE PORT, LEONARD, 10F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10744472
• Report Number: 3006260740-2020-03529
• Device Sequence Number: 14474855
• Product Code: LJT
• UDI-Device Identifier: 00801741026119
• UDI-Public: (01)00801741026119
• 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): 01/27/2021

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: 0607200
• Device Catalogue Number: 0607200
• Device Lot Number: RERH1014
• 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: 01/27/2021
• Patient Sequence Number: 1