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 Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2017

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 rexf1938 showed no other similar product complaint(s) from this lot number.Device not yet returned.

Event Description

It was reported by nurse that the catheter was used on (b)(6) 2017 and was unable to be preflushed because the valves would not open.No patient harm was reported.

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 that the valve failed to open for aspiration was confirmed, and could be associated with the valve length, which was below specification.One 4 fr s/l groshong picc was returned for investigation.The catheter was received with the stylet in the lumen.The red hang tag was not attached to the catheter.Repeated functional tests of the catheter confirmed that the valve failed to open inward for aspiration without the stylet in the lumen.The valve opened during infusion and allowed fluid to exit the distal end of the catheter.The valve length was found to be below specification, which may have been a factor in the reported complaint.The sample was forwarded to the manufacturing facility for further review.While testing for aspiration, a leak was observed between the 34 and 35 cm depth marks.The leak site revealed a pattern of holes in the tubing that resembled the twist in the stylet wire.It appeared that the catheter was compressed against the stylet and it is possible that the catheter was damaged while in transit to bd for investigation or sometime after the reported event.The leak was evident during the functional testing in the lab and had the leak existed while the complainant was flushing the sample in the field, it should have been observed.Since no mention of a leak was made by the complainant, it was determined that the catheter was damaged sometime after the reported event, such as when the sample was returned to bd for investigation.One of the precautions in the ifu states, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.¿ reynosa evaluation: according to evaluation 4fr single lumen groshong catheter tip was found the ¿the valves unable to be opened¿ confirmed as manufacturing related.Based in functional testing realized by bas was concluded that the valve slit was incorrect.A lot history review (lhr) of rexf1938 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by nurse that the catheter was used on (b)(6) 2017 and was unable to be preflushed because the valves would not open.No patient harm was reported.

• 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: 7087974
• MDR Text Key: 94377924
• Report Number: 3006260740-2017-02191
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7617405
• Device Lot Number: REXF1938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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: 42 YR
• Patient Weight: 50