MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPCLRVUE ISP 8FPU SIOM; IMPLANTABLE PORT

Model Number 5608062

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

Patient Problems Wound Dehiscence (1154); Skin Erosion (2075)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was provided, a manufacturing review was not required to be performed.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.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged port incision redness and tiny hole "not healing" issue due to the fact that no sample was returned for evaluation.Although a definitive root cause could not be determined, the following contributing factor improper placement technique could have potentially caused or contributed to the reported event.(expiration date: 02/2021).

Event Description

It was reported that some time post port device implant, the patient experienced redness and presence of a hole at the incision site.Reportedly, the patient was recommended to seek assessment of the incision site by an emergency room physician.The patient status is unknown.

• Brand Name: PPCLRVUE ISP 8FPU SIOM
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9856394
• MDR Text Key: 184288050
• Report Number: 3006260740-2020-00891
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027369
• UDI-Public: (01)00801741027369
• Combination Product (y/n): N
• PMA/PMN Number: K122899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5608062
• Device Catalogue Number: 5608062
• Device Lot Number: REDW1451
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other