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); Defective Component (2292); 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).Device pending return.

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: one flushing connector was returned for evaluation.Gross visual, functional and microscopic evaluations were performed.Although sample was returned for evaluation, one video was provided for review.The investigation is confirmed for the reported unable to flush and obstruction of flow issue, as the flushing connector could not be flushed nor aspirated.Destructive testing was performed on the device by breaking the metal from the hub.An unknown white, plastic-like material obstructing the flow path of the flushing connector was identified.The occlusion material was determined to be excess material from the hub itself and prevented a proper flushing of the device.This condition was caused during the over-molding process.Therefore, the cause of this condition is manufacturing related.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.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 : see h10.

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: 11000806
• MDR Text Key: 221246973
• Report Number: 3006260740-2020-20913
• 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: 06/24/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 07/29/2021
• 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