MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 5829502

Device Problems Complete Blockage (1094); Fracture (1260); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that post port device implant, the septum of the device was allegedly dislodge and ruptured.The device was removed.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 05/2022) 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 post port device implant, the septum of the device was allegedly dislodges and ruptured.The device was removed.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the forth complaint reported for this product/lot number combination.A device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport duo mri implantable port attached to a catheter were returned for evaluation.Visual, microscopic visual, tactile and functional evaluation were performed on the returned device.The investigation is confirmed for the reported port septum dislodged issue as the right port septum was noted to have partially dislodged from the port base.The investigation is also confirmed for the identified complete blockage issue as resistance was noted upon infusing and aspirating through the right port septum and blockage was noted upon inserting scientific guidewire and pin gauge on the right septum.However, the investigation is unconfirmed for the reported port septum rupture as no fracture or rupture was identified on the port septum.A definitive root cause could not be determined.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 (expiry date: 05/2022).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.H3 other text : see h10.

Event Description

It was reported that post port device implant, the septum of the device was allegedly dislodge and ruptured.The device was removed.There was no reported patient injury.

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11449775
• MDR Text Key: 238841897
• Report Number: 3006260740-2021-00757
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027406
• UDI-Public: (01)00801741027406
• Combination Product (y/n): N
• PMA/PMN Number: K090512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5829502
• Device Catalogue Number: 5829502
• Device Lot Number: REEV2356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other