MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE IMPLANTABLE PORT WITH ATTACHABLE 8F POLYURETHANE OPEN-ENDED; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1608062

Device Problems Suction Problem (2170); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.

Event Description

It was reported that blood return was not present when the port was accessed.There was no reported patient injury.

Manufacturer Narrative

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.This is the first complaint reported for this lot number and issue to date.The quantity affected is one unit.Investigation summary: one powerport clearvue isp with 8fr s/l catheter was returned for evaluation.The device functioned properly under laboratory conditions, the port was patent o both infusion and aspiration without any leaks.Therefore, the investigation is unconfirmed for the alleged failure to aspirate.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11:section a through f - the information provided by bard 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 bard.

Event Description

It was reported that blood return was not present when the port was accessed.The device was removed.There was no reported patient injury.

• Brand Name: POWERPORT CLEARVUE IMPLANTABLE PORT WITH ATTACHABLE 8F POLYURETHANE OPEN-ENDED
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7660486
• MDR Text Key: 113161872
• Report Number: 3006260740-2018-01606
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026430
• UDI-Public: (01)00801741026430
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1608062
• Device Catalogue Number: 1608062
• Device Lot Number: REAX1804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 128