MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI, 9.6 FR. SILICONE, INTER. KIT W/SUTURE PLUG, S/L; IMPLANTABLE PORT

Model Number 1859600

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

Patient Problems Irritation (1941); Itching Sensation (1943); Local Reaction (2035)

Event Date 02/16/2020

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.Photos were provided for review.The device was not returned to the manufacturer for evaluation.The investigation is currently under way.Medical device - expiration date: 05/2021.

Event Description

It was reported that approximately two days post port implant, the patient allegedly experienced redness, irritation, hives and itches around the port insertion site.Therefore, the patient received prescribed medication.Reportedly, the healthcare provider used hypoallergenic dressing for cleaning during port access.The patient was reported as stable.

Manufacturer Narrative

H10: manufacturing review: the lot number was provided and a lot history review was performed.Investigation summary: the sample was not returned for evaluation.Five electronic photos were provided and reviewed.One of the photos shows labeling for a powerport mri implantable port.The product catalog number and lot number are visible on the labeling.The remaining four photos show regions of redness and what appears to be scabbing and peeling on the patient¿s chest near the neck and on the neck.The four photos showing the regions of redness appear to have time stamps; however, actual dates cannot not be discerned from the photos provided.The port is not visible in any of the photos.The photo review is inconclusive for the device causing or contributing to the reported allergic reaction.The investigation is inconclusive for the device causing or contributing to the reported allergic reaction, as the photo review could not identify any device deficiencies.The definitive root cause could not be determined based upon available information, as a device deficiency could not be identified in the photo review.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 ifu instructs on port implantation and that the nursing guide instructs on preoperative skin preparation.Therefore, the product labeling will be considered adequate.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 two days post port implant, the patient allegedly experienced redness, irritation, hives and itches around the port insertion site.Therefore, the patient received prescribed medication.Reportedly, the healthcare provider used hypoallergenic dressing for cleaning during port access.The patient was reported as stable.

• Brand Name: POWERPORT MRI, 9.6 FR. SILICONE, INTER. KIT W/SUTURE PLUG, S/L
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9887067
• MDR Text Key: 186527447
• Report Number: 3006260740-2020-01087
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027208
• UDI-Public: (01)00801741027208
• Combination Product (y/n): N
• PMA/PMN Number: K073423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 1859600
• Device Catalogue Number: 1859600
• Device Lot Number: REDY1483
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZYRTEC; ZYRTEC
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 68