MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE IMPLANTABLE PORT WITH ATTACHABLE 6F POLYURETHANE OPEN-ENDED; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1606062

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

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 a few hours after the port was placed, the catheter flipped up.The device was removed and another device was placed.There was no reported patient injury.

Manufacturer Narrative

The lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.One powerport vue mri w/ 6 fr s/l white polyurethene catheter was returned for evaluation.The catheter segment was connected to the port stem under a catheter lock.Blood and fluid residue were noted throughout the sample.No anomalies were noted to the sample.The sample was patent to infusion and aspiration with no leaks observed.Although no issue could be confirmed with the returned sample, the investigation is inconclusive for the reported catheter malposition as the conditions of us could not be accurately recreated.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Possible contributing factors include placement technique and securement technique.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that a few hours after the port was placed, the catheter flipped up.The device was removed and another device was placed.There was no reported patient injury.

• Brand Name: POWERPORT CLEARVUE IMPLANTABLE PORT WITH ATTACHABLE 6F 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: 7660914
• MDR Text Key: 113168905
• Report Number: 3006260740-2018-01618
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026416
• UDI-Public: (01)00801741026416
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

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: 1606062
• Device Catalogue Number: 1606062
• Device Lot Number: RECR1667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 68