MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 7617405

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

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

Event Date 06/06/2018

Event Type  malfunction  

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 evaluate.Results are expected soon.A lot history review (lhr) of rebq0594 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the patient, who was diagnosed with lung cancer, received implantation of a three-way valve picc on (b)(6) 2018.The catheterization was conducted by a picc outpatient nurse, who underwent ultrasound-guided seldinger technique on the right upper limb of the patient to implant the picc and the process was smooth.During the maintenance of flushing the catheter on (b)(6) it was found that the exposed part of the catheter was leaking.The leaking part of the catheter can not be fixed after being trimmed.Pulling it out will cause the tip to be out of the optimal position.The nurse was afraid that other parts may leak and cannot be used for chemotherapy drug infusion.Six cycles of chemotherapy remained, so the catheter was removed.The nurse in charge was a member of the picc team in the hospital.The feedback catheter was used in the hospital after placement, and the operation was standardized.It was stated that leakage resulted in failure to complete the chemotherapy regimen.

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 leak is inconclusive due to poor sample condition.One 4 fr single lumen groshong nxt catheter and a split introducer sheath were returned for investigation.The catheter extended 23 mm from the distal end distal end of the connector.The distal end appeared to have been cut.The other segment was not returned.The sample was flushed with water using a 10 ml syringe and was found to be patent to infusion.The catheter was pressurized and no leaks were observed.Microscopic observation of the distal end revealed sharp edges and striation patterns on the break surface which is indicative of the a sharp instrument cut.As it is unknown if the unreturned segment of the catheter contained the leak and the returned segment appeared to be intentionally cut, the complaint is inconclusive due to poor sample condition.A lot history review (lhr) of rebq0594 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the patient, who was diagnosed with lung cancer, received implantation of a three-way valve picc on (b)(6) 2018.The catheterization was conducted by a picc outpatient nurse, who underwent ultrasound-guided seldinger technique on the right upper limb of the patient to implant the picc and the process was smooth.During the maintenance of flushing the catheter on (b)(6), it was found that the exposed part of the catheter was leaking.The leaking part of the catheter can not be fixed after being trimmed.Pulling it out will cause the tip to be out of the optimal position.The nurse was afraid that other parts may leak and cannot be used for chemotherapy drug infusion.6 cycles of chemotherapy remained, so the catheter was removed.The nurse in charge was a member of the picc team in the hospital.The feedback catheter was used in the hospital after placement, and the operation was standardized.It was stated that leakage resulted in failure to complete the chemotherapy regimen.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7646955
• MDR Text Key: 112895243
• Report Number: 3006260740-2018-01513
• 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,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7617405
• Device Catalogue Number: 7617405
• Device Lot Number: REBQ0594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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