MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8806061

Device Problems Complete Blockage (1094); Difficult to Flush (1251); Obstruction of Flow (2423)

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

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, video was provided for review.The investigation of the reported event is currently underway.(expiry date: 10/2021).

Event Description

It was reported that prior to a port placement through right internal jugular vein for a postoperative auxiliary chemotherapy, the port allegedly unable to flushed and obstructed.The procedure was completed using another port.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this product/lot number combination.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the sample was not returned for evaluation, one electronic video was provided for review.The video shows the clinician trying to flush the flushing hub by connecting the flushing hub to a syringe.Upon pressing the syringe plunger, no fluid was found passing through the flushing hub despite many attempts.Based on the video review, the investigation is confirmed for the reported difficult to flush and complete blockage.The 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 expiry date:(10/2021), g3.H11: h6(device, results, conclusion).H11: section a through f: the information provide by bd represents all 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 : device not returned.

Event Description

It was reported that prior to a port placement through right internal jugular vein for a postoperative auxiliary chemotherapy, the port allegedly unable to flushed and obstructed.The procedure was completed using another port.There was no patient contact.

• Brand Name: POWERPORT ISP MRI 6F CHRONW/OS
• 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: 11001361
• MDR Text Key: 221235143
• Report Number: 3006260740-2020-20916
• Device Sequence Number: 1
• Product Code: LJT
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8806061
• Device Lot Number: REDY3934
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 52