MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TI POWERPORT LOW PROFILE - JAPAN ONLY; IMPLANTABLE PORT

Catalog Number 1716000J

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994)

Event Date 01/18/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will 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.(b)(4).(expiration date: 03/2020).

Event Description

It was reported that approximately one year one month and fifteen days post port implant, the patient allegedly experienced fever, redness and pain around the insertion site.The healthcare provider suspected infection; therefore, anti-infective therapy and blood culture were performed.Reportedly, the port device was removed and upon removal an alleged blood loss was observed around the insertion site.The patient was reported unrecovered.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: a sample evaluation could not be performed, as the device was not returned therefore the investigation is inconclusive for the alleged issues.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: b6, d4 (expiration date: 03/2020), g4, h4, h6 (patient 2597 - blood loss) h11: b5, h6 (device code and 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 year one month and fifteen days post port implant, the patient allegedly experienced fever, redness and pain around the insertion site.Reportedly, for suspected infection, the healthcare provider performed blood culture and administered anti-infective treatment.It was further reported that the port device was removed and upon removal blood loss was identified around the insertion site.The patient was reported unrecovered.

• Brand Name: TI POWERPORT LOW PROFILE - JAPAN ONLY
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9727612
• MDR Text Key: 180176814
• Report Number: 3006260740-2020-00547
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111631
• UDI-Public: (01)00801741111631
• Combination Product (y/n): N
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1716000J
• Device Lot Number: RECR1873
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTI INFECTIVE THERAPY; ANTI INFECTIVE THERAPY
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 84