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)

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

Event Date 11/12/2020

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 subclavian vein, the port allegedly unable to flush.The procedure was completed using another port.There was no patient contact.

Event Description

It was reported that prior to a port placement through right subclavian vein, the port was allegedly unable to flush.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 eight complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: one powerport mri isp, one catheter, one flushing connector, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, one vein pick, two catheter locks, one syringe, one guidewire in a guidewire hoop, one introducer peel-apart sheath along with vessel dilator and one tunneler were returned for evaluation.Functional, gross visual, dimensional and microscopic visual evaluations were performed.Although sample was returned for evaluation, one video was provided for review.The investigation is confirmed for the reported difficult to flush and obstruction issue, as a great resistance was met upon infusion and aspiration of the flushing connectors and only droplets were able to pass through the distal end of the device.A pin gauge was used to inspect the bore of the pin gauge and clear blockage was observed within the flushing connector.Destructive testing was performed on the flushing connector to break the metal cannula from the hub.Upon observation down the bore of the flushing connector, a white unknown plastic-like material was noted occluding the flow path of the sample.The cause of the flushing connector occlusion and unable to flush issue was identified to be manufacturing related, as condition was caused during the over-molding process.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: the catalog number identified in section d4 has not been cleared in the us, but is similar to the powerport implantable port products that are cleared in the us.The pro code and 510k number for the powerport implantable port products is identified in d2 and g4.H10: d4 (expiry date: 10/2021).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.

• 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: 11000803
• MDR Text Key: 221241547
• Report Number: 3006260740-2020-20914
• 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: REDY0881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 55