MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT, TI, ISP, 6FR CHRONOFLEX, INTER. W/O SUTURE PLUG; IMPLANTABLE PORT

Model Number	1706061
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Skin Erosion (2075)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: a sample evaluation could not be performed as the samples were not returned.The investigation is inconclusive for port eroding through skin.Although a definitive root cause could not be determined, loose or severed sutures, external mechanical port manipulation, inappropriate port geometry or material, or shallow port depth of placement could have potentially caused or contributed to the reported event.Medical device - expiration date: 01/2021.
Event or Problem Description
It was reported that some time post port device implant, the port allegedly eroded through the skin.Reportedly, the patient is scheduled for port device replacement.The patient's status is reported as stable.

• Brand Name: POWERPORT, TI, ISP, 6FR CHRONOFLEX, INTER. W/O SUTURE PLUG
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8944445
• Report Number: 3006260740-2019-02520
• Device Sequence Number: 16774619
• Product Code: LJT
• UDI-Device Identifier: 00801741026553
• UDI-Public: (01)00801741026553
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1706061
• Device Catalogue Number: 1706061
• Device Lot Number: REDP3367
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 59