MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNK PORT

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation; however, image and video were provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that approximately three years post port device implant, the port was allegedly found fractured and migrated into the inferior vena cava.It was further reported that the port was removed.There was no patient injury reported.

Manufacturer Narrative

H10: manufacturing review: a lot history review, a dhr review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not returned for evaluation; however, two medical images and one video using a medical imaging modality were provided for review.The investigation is confirmed for a complete catheter break and catheter fragment migration, as the medical image evaluation identified fractured port catheter tubing near the entrance into the left internal jugular vein with migration of the distal tubing into the superior vena cava.The distal tubing was identified as being removed using a left internal jugular vein approach with a snare and sheath.A definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.

Event Description

It was reported that approximately three years post port device implant, the port was allegedly found fractured and migrated into the inferior vena cava.It was further reported that the port was removed.There was no patient injury reported.

• Brand Name: UNKNOWN PORT
• 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: 10287640
• MDR Text Key: 199234774
• Report Number: 3006260740-2020-02506
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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: UNK PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention