MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPCVSLIMSPNB6CFINT; IMPLANTABLE PORT

Model Number	1676300
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device will be returned to bd for evaluation.The return of the device is pending.A photo and x-ray were provided for review.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model 1676300 implantable port experienced a break.This report was received from one source.One patient was involved with no patient consequences.Patient age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model 1676300 implantable port experienced a break.This report was received from one source.One patient was involved with no patient consequences.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
The lot number was provided, and lot history review was performed.The device was not returned for evaluation.However, 3 medical images and 5 electronic photos were provided.The investigation is unconfirmed for break, but confirmed for dislodgement.

• Brand Name: PPCVSLIMSPNB6CFINT
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8527688
• Report Number: 3006260740-2019-00932
• Device Sequence Number: 1928592
• Product Code: LJT
• UDI-Device Identifier: 00801741110764
• UDI-Public: (01)00801741110764
• 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): 07/24/2019

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: 1676300
• Device Catalogue Number: 1676300
• Device Lot Number: RECU2414
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1