MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4FR, 18GA 57CM GROSHONG CATHETERS; CATHETER, PERCUTANEOUS

Catalog Number UNKNOWN

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been received by the manufacturer for evaluation.A lot history review (lhr) review is not possible; as no manufacturing lot number has been provided.

Event Description

Per jvir study: seven (7) occlusions were reported for distal valved catheters.¿the declotting procedure entailed injection of 2mg recombinant tissue plasminogen activator in 2ml normal saline solution into the occluded catheter, which was left clamped for 30 minutes.If flow was not reestablished, a second does was instilled and the catheter was clamped for 24 hours.If the catheter remained occluded, it was replaced.¿ (p 1175).¿the 4fr, 18ga 57cm groshong catheters were placed in the lower superior vena cava with the hub extending 7cm from the skin entry.The catheters were affixed near the skin entry site by suture to the catheter, and then the flange was sutured to the skin.The sites were dressed with 1-inch cotton gauze and covered with a clear sterile bandage (tegaderm).No antibiotic ointment was used.The catheters were flushed with saline solution.The protocol for line care included a saline flush after each use or every 8 hours.Dressings were changed at 48 hours and then every 7 days, or as needed.¿ (p 1174).Reference: hoffer, e.K., bloch, r.D., borsa, j.J., santulli, p., fontaine, a.B., & francoeur, n.(2001).Peripherally inserted central catheters with distal versus proximal valves: prospective randomized trial.Journal of vascular and interventional radiology, 12, 1173¿1177.Https://www.Sciencedirect.Com/science/article/pii/s1051044307616765.

• Brand Name: 4FR, 18GA 57CM GROSHONG CATHETERS
• Type of Device: CATHETER, PERCUTANEOUS
• 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. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 8259371
• MDR Text Key: 133518814
• Report Number: 3006260740-2019-00050
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/17/2019
• 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): Required Intervention