MAUDE Adverse Event Report: ANGIODYNAMICS LATHAM NEOSTAR CATHETER; CENTRAL VENOUS CATHETER

Model Number CV-33WEK

Device Problems Connection Problem (2900); Infusion or Flow Problem (2964)

Patient Problem Cancer (3262)

Event Date 09/04/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014 the patient with a history of acute myeloid leukemia status post allogenic transplant on (b)(6) 2013 called (b)(6) to report that he was in a (b)(6) and while getting his central line dressing changed the while lumen on the tl neostar catheter was leaking below the clamp but above the cap/hub when flushed.The patient was told to come to (b)(6) to have the neostar catheter removed.On (b)(6) 2014 at 1430, the patient had the following procedure complete.Indication: aml, bmt.Treatment completed.White lumen leaking at hub detail: patient laying flat.Lines aspirated and secured closed.Dressing removed.Sterile technique throughout, prepped and draped in sterile fashion.Site anesthetized with approximately 5 ml of 1 percent lidocaine with epinephrine.Suture removed.Good analgesia was achieved.Blunt dissection to cuff with manual and sharp disruption of significant fibrous adhesions.Patient with maximal inhalation and performing valsalva maneuver, line was removed under direct proximal and distal pressure continuously applied for greater than 5 minutes.No signs of infection by gross examination.Sterile, occlusive dressing applied.No bleeding.No complications.Tolerated well.Disposition: successful removal of tunneled cvc without complication.Instructions given verbal and in writing.Patient understands.All questions answered.A patient safety net was completed regarding this event documenting device failure, including product identifiers.The defective catheter was returned to the company for evaluation.

• Brand Name: NEOSTAR CATHETER
• Type of Device: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS LATHAM; NY
• MDR Report Key: 4360623
• MDR Text Key: 21553640
• Report Number: 4360623
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: CV-33WEK
• Device Lot Number: 4773693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/04/2014
• Event Location: Outpatient Treatment Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTIEMETICS AND A FENTANYL PCA.; TRANSPLANT INCLUDING BLOOD PRODUCTS,; DISCHARGE DATE: (B)(6) 2014. DURING TRANSPLANT; CONCOMITANT TREATMENT FOR BONE MARROW; ANTIBIOTICS, PLATELET AND PRBC INFUSIONS, IVF, IV; MULTIPLE MEDICATIONS. ADMISSION DATE: (B)(6) 2014; RECEIVED MULTIPLE PRODUCTS INCLUDING IV
• Patient Age: 43 YR
• Patient Weight: 90