MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT SLIM IMPLANTABLE PORT WITH ATTACHABLE 6F POLYURETHANE OPEN-ENDED S/L; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1716070
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that the port had been in place for approximately four and a half years and used with no problems when the port was accessed to administer iv contrast for a ct ivp and the patient felt pain.It was also reported that the nurses noticed slight swelling at the port site during injection of the contrast.A port-a-gram was performed and showed a fracture of the catheter with the contrast extravasation around the tubing closest to the port.The port was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one powerport ti low profile with suture plugs was received for evaluation.Visual and microscopic inspection noted a partial circumferential break 1mm distal to the cath-lock.The type of break could not be determined, therefore, the investigation is confirmed for the alleged subcutaneous leak.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that the port had been in place for approximately four and a half years and used with no problems when the port was accessed to administer iv contrast for a ct ivp and the patient felt pain.It was also reported that the nurses noticed slight swelling at the port site during injection of the contrast.A port-a-gram was performed and showed a fracture of the catheter with the contrast extravasation around the tubing closest to the port.The port was removed and replaced.There was no reported patient injury.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT WITH ATTACHABLE 6F POLYURETHANE OPEN-ENDED S/L
• 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: 8046060
• Report Number: 3006260740-2018-03166
• Device Sequence Number: 1625126
• Product Code: LJT
• UDI-Device Identifier: 00801741026768
• UDI-Public: (01)00801741026768
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: Health Professional
• Device Model Number: 1716070
• Device Catalogue Number: 1716070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR