MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F

Model Number 1616001

Device Problem Inadequate User Interface (2958)

Patient Problem Edema (1820)

Event Date 07/10/2020

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.The device has not been returned to the manufacturer for evaluation, however images have been provided.The investigation of the reported event is currently underway.(expiration date: 03/2021).

Event Description

It was reported some time post port implantation procedure that, the palpation bumps of the port allegedly cannot be felt.It was further reported that, the patient was hospitalized and completed antibiotic treatment.The patient status was unknown.

Event Description

It was reported some time post port implantation procedure, the palpation bumps of the port allegedly cannot be felt.It was further reported that, the patient was hospitalized and completed antibiotic treatment.The patient status was unknown.

Manufacturer Narrative

H10: manufacturing review:a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation, however, one medical image was provided for review.The investigation is inconclusive for unable to feel palpation bumps as the exact circumstances at the time of the reported event are unknown.A definitive root cause could not be determined based upon available information.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: d4 (expiration date: 03/2021),g4.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.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10435512
• MDR Text Key: 203813377
• Report Number: 3006260740-2020-03012
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026454
• UDI-Public: (01)00801741026454
• Combination Product (y/n): N
• PMA/PMN Number: K122899
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1616001
• Device Catalogue Number: 1616001
• Device Lot Number: REEN4964
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other