MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG PORT S/L; IMPLANTABLE PORT

Catalog Number UNK GROSHONG PORT S/L

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problem Injury (2348)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.The sample was not returned for evaluation, however,one electronic photo and two medical images were provided for review.The investigation is confirmed for the reported catheter break, material separation and migration issue as complete break was observed on the catheter between 15-20 distal mark.Also, the catheter tubing is broken at the catheter insertion into the left internal jugular vein.The distal fractured catheter tubing has migrated into the superior vena cava and extends into the right heart.A 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.

Event Description

It was reported that some time post catheter placement, the catheter was allegedly broken inside the patient.The patient status was unknown.

• Brand Name: GROSHONG PORT S/L
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11312354
• MDR Text Key: 231304929
• Report Number: 3006260740-2021-80026
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK GROSHONG PORT S/L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other