MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Model Number 7617405

Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem No Code Available (3191)

Event Date 02/25/2018

Event Type  Injury  

Manufacturer Narrative

The information provided by bard represents all of 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 bard.The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reaw0623 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by nurse that the catheter was placed into the patient in (b)(6) 2017 and left for 3 months.The patient planned to remove the picc when discharged at the end of treatment.There was a slight resistance when the catheter was pulled to the armpit.No catheter tip was seen after the catheter was pulled out and under x-ray imaging, it was found that the catheter tip 2cm rupture left in the patient's axillary vein.The catheter was removed through interventional operation then, with the fracture section tidy.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a break in the catheter was confirmed, and based on the reported event, it was determined that the catheter broke during use.One 4 fr s/l groshong picc was returned for investigation.The catheter exhibited evidence of use.The stylet had been removed and the catheter was received with the connector attached and secured to the tubing.Residue was observed on the two-piece connector.The printing was worn from the extension leg.The 44cm depth mark coincided with the distal tip of the strain relief oversleeve.A 5cm segment of tubing was discolored just distal to the strain relief oversleeve.The distal 2.6cm segment of catheter tubing was received separate from the remainder of the catheter.A microscopic examination revealed that the adjoining surfaces of the catheter were smooth and granular, which is indicative of a break/tear in the tubing material.It was reported that resistance was noted during catheter removal.The product ifu states, ¿grasp catheter near insertion site.Remove slowly.Do not use excessive force.If resistance is felt, stop removal.Apply warm compress and wait 20-30 minutes.Resume removal procedure.¿ no further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot.A lot history review (lhr) of reaw0623 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by nurse that the catheter was placed into the patient in (b)(6) 2017 and left for 3 months.The patient planned to remove the picc when discharged at the end of treatment.There was a slight resistance when the catheter was pulled to the armpit.No catheter tip was seen after the catheter was pulled out and under x-ray imaging, it was found that the catheter tip 2cm rupture left in the patient's axillary vein.The catheter was removed through interventional operation then, with the fracture section tidy.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER
• Type of Device: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
• 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: 7360221
• MDR Text Key: 103135598
• Report Number: 3006260740-2018-00493
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 7617405
• Device Catalogue Number: 7617405
• Device Lot Number: REAW0623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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