MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPRT MRI ISP 8GR; IMPLANTABLE PORT

Model Number	1808551
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot numbers for both of the malfunctions were provided and lot history reviews were performed.The devices were not returned for evaluation, therefore the investigations are inconclusive for the reported failure as no objective evidence was provided.The definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 1808551 implantable port allegedly experienced a missing component.This information was received from various sources.No patients were involved and patient information was not provided.

• Brand Name: PPRT MRI ISP 8GR
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9211144
• Report Number: 3006260740-2019-03195
• Device Sequence Number: 19597532
• Product Code: LJT
• UDI-Device Identifier: 00801741027109
• UDI-Public: (01)00801741027109
• 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: 1808551
• Device Catalogue Number: 1808551
• Device Lot Number: REBZ0744, RECT0966
• 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