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 N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2017

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rezl2260 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.

Event Description

It was reported by nurse that the left hand was selected for puncture via basilic vein.The catheter was preflushed, and the puncture conducted, the catheter was delivered into the target position smoothly, while return blood ocuured soon.After that, the saline was used for flushing.It was stated that blood occurred again without the pressure from flushing.The client reported they believe that the valves had been damaged.No harm to the patient.

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 bleedback was inconclusive due to the nature of the complaint and potential factors associated with the clinical setting.Two groshong 4 fr s/l piccs were received with the stylet in the lumen.It appears that each catheter had been repositioned over the metal cannula of the stylet.The catheters were positioned approximately 1.5mm over the stem.A microscopic examination of the groshong 3-position valve revealed nothing remarkable.A functional test revealed that the catheters were patent to infusion and no leaks were identified.The groshong 3-position valves were submerged in water and the remainder of the catheter was draped over the edge of the beaker and into the sink below the level of the valve to create a siphon within the picc.The complication of bleedback could not be replicated on the returned devices.The valve remained closed and would not allow water to be drawn through the picc line.Possible causes of bleedback include migration or placement of the catheter tip in the internal jugular vein, or vessel other than the superior vena cava, or coiling of the catheter in a vein may position the catheter tip where the valve is pushed open.

Event Description

It was reported by nurse that the left hand was selected for puncture via basilic vein.The catheter was preflushed, and the puncture conducted, the catheter was delivered into the target position smoothly, while return blood occured soon.After that, the saline was used for flushing.It was stated that blood occurred again without the pressure from flushing.The client reported they believe that the valves had been damaged.No harm to the patient.

• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6616913
• MDR Text Key: 76962586
• Report Number: 3006260740-2017-00731
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991(17)200528(10)REZL2260
• Combination Product (y/n): N
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

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 Expiration Date: 05/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 7617405
• Device Lot Number: REZL2260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 07/12/2017
• Supplement Dates FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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 Age: 32 YR
• Patient Weight: 55