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

Catalog Number UNK APHERESIS PORT ACCESS SYS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Skin Erosion (2075)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not 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.

Event Description

It was reported that approximately one year post placement, cancer medication was infused and allegedly the port eroded through the skin.Reportedly, the device was removed and a culture found an infection on the port.The current patient status is unknown.

Manufacturer Narrative

Manufacturing review: a lot history record could not be completed as the lot number was not provided.Investigation summary: although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for port erosion through the skin, as the photo shows device visible through a hole in the patient¿s skin.The device appears consistent with a powerflow port.Redness is visible around the hole, and what appears to be scabbing.Although a definitive root cause could not be determined, placement of the device under too thin a layer of tissue, or in an area where it could not be properly stabilized, improper access methods (e.G., non-sterile), or traumatic device characteristics could have potentially caused or contributed to the reported event.In addition, it is mentioned in the report that because the patient is on steroids he has thinner skin.No sterilization release can be obtained because the lot number was not included in the report.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.

Event Description

It was reported that approximately one year post placement, cancer medication was infused and allegedly the port eroded through the skin.Reportedly, the device was removed and a culture found an infection on the port.The current patient status is unknown.

• Brand Name: APHERESIS PORT ACCESS SYSTEM
• 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: 8565899
• MDR Text Key: 143587305
• Report Number: 3006260740-2019-01221
• Device Sequence Number: 1
• Product Code: PTD
• Combination Product (y/n): N
• PMA/PMN Number: K163001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK APHERESIS PORT ACCESS SYS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR