MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER PORT MRI ISP, 8 FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8808560

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date (06/2018).

Event Description

It was reported that some time post port placement, that the catheter allegedly broke and migrated to the vena cava and right atrium.It was further reported that the migrated portion of the device and the port body were removed.Patient status is unknown.

Event Description

It was reported that some time post port placement, that the catheter allegedly broke and migrated to the vena cava and right atrium.It was further reported that the migrated portion of the device and the port body were removed.Patient status is unknown.

Manufacturer Narrative

H10: as the lot number for the device was provided, a manufacturing review will be 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 instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 expiry date (06/2018), g4 h11: h6 (method, result, conclusion) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: POWER PORT MRI ISP, 8 FR. GROSHONG, INT W SP, ATTACHABLE SL
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10287608
• MDR Text Key: 199228301
• Report Number: 3006260740-2020-02505
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098994
• UDI-Public: (01)00801741098994
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8808560
• Device Lot Number: REAT1311
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention