MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PP CV SLIM MR 8F WITH OPEN SUTURE HOLES - INTERMEDIATE KIT; IMPLANTABLE PORT

Model Number	1618001
Medical Device Problem Code	Suction Problem (2170)
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 malfunction; therefore a review of the device history records is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event 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.The information reviewed indicated that model 1618001 implantable port allegedly experienced a suction problem and was unable to aspirate.This report was received from one source.Age, weight, and gender were not provided for the patient.There was no reported patient injury.

• Brand Name: PP CV SLIM MR 8F WITH OPEN SUTURE HOLES - INTERMEDIATE KIT
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9209884
• Report Number: 3006260740-2019-03167
• Device Sequence Number: 305761
• Product Code: LJT
• UDI-Device Identifier: 00801741026492
• UDI-Public: (01)00801741026492
• 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
• Report Date (Section B): 10/18/2019

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: 1618001
• Device Catalogue Number: 1618001
• Device Lot Number: REBY0049
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1