MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F DIGNITY CT PORT

Device Problems Leak/Splash (1354); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated.Additional information and the return of the sample for evaluation has been requested.

Event Description

The port was not placed at this hospital.The patient came from another hospital.When the port was accessed in the er the huber needle could not be pulled out.The patient was sent to ir for a port check.The needle had penetrated the base of the port.

Manufacturer Narrative

The 8f dignity port was received for evaluation.Additional information was requested from the reporting facility.Dr.(b)(6) indicated that he cannot answer the questions and would not compete the product incident report.They did not place the port at their hospital.The patient came from another hospital.The port was accessed in the er and then the patient was sent to ir for a port check because they could not pull out the huber needle.Visual examination confirmed the report.There is a hole through the base of the port that leaks when the port is flushed.The septum was removed in order to obtain dimensions.The port floor shows some minor scratches with the one through and through puncture hole.Relative dimensions were taken, including the thickness of the port floor thickness which measured.040 putting it within specification of between.035 and.045.All dimensions taken show the device is within specification.The contract manufacturer conducted a review of the manufacturing records for the lot reported.The review showed the device was manufactured according to specification with no anomalies or non-conformances.Product validation determined the average force required to pierce the port base floor with 19 and 22 gauge huber style needles.For the 19 gauge needle the average force was 15.91 lbs with a minimum force of 14 lbs.For the 22 gauge needles the needles bent at an average force of 4.62 lbs and did not penetrate the base floor.We are unable to determine the cause of this event.Excessive force may have been used when accessing the port.The health professional inserting the needle into the port may have misjudged the depth of the port and the amount of force necessary to access the port, thus causing the needle to go through the port base.

• Brand Name: 8F DIGNITY CT PORT
• Type of Device: DIGNITY CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8959368
• MDR Text Key: 156391867
• Report Number: 2518902-2019-00057
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention