MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNK POWER PORT DUO; PORT & CATHETER, IMPLANTED, INTRAVASCULAR, SUBCUATNEOUS

Catalog Number UNK POWER PORT DUO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Chills (2191)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(b)(4).

Event Description

It was reported that approximately one month post port placement, the patient presented with a fever and chills.The patient was then admitted to the hospital due to an alleged infected port and was then diagnosed with (b)(6) infection.It was further reported that the port was removed.The patient was reportedly hemodynamically stable.

Manufacturer Narrative

H10: manufacturing review: a lot history record could not be completed as the lot number was not provided.Investigation summary: one clearvue port was returned for evaluation.A visual, microscopic and functional evaluations were performed.The investigation is unconfirmed for the reported infection issue to the device, as the port body with attached catheter segment was patent to infusion and aspiration.Blood was noted exiting the catheter segment.Multiple punctures were observed on the port septum.Striations were noted on the edge of the break.Furthermore, the surface of the break appeared smooth and glossy.The catheter appeared cut as it could be due to removal of the device from patient.Although a definitive root cause could not be determined, improper placement technique could have potentially caused or contributed to the reported event.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.H10: g4, h6 (patient code: 2058 - staphyloccus aureus).H11: h3, h6 (results, 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.

Event Description

It was reported that approximately one month post port placement, the patient presented with a fever and chills.The patient was then admitted to the hospital due to an alleged infected port and was then diagnosed with methicillin-resistant staphylococcus aureus (mrsa) infection.It was further reported that the port was removed.The patient was reportedly hemodynamically stable.

• Brand Name: UNK POWER PORT DUO
• Type of Device: PORT & CATHETER, IMPLANTED, INTRAVASCULAR, SUBCUATNEOUS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9981418
• MDR Text Key: 188355336
• Report Number: 3006260740-2020-01446
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK POWER PORT DUO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization