MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

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 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 an exposed stiffening stylet was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l groshong catheter.The sample was received with an inlaid tls 3cg stylet.Usage residues were observed throughout the sample.The tip of the stylet protruded from the 3-way valve.The length of the catheter was measured to be 59.8cm.The length of the stylet was measured to be 72.2cm from the handle assembly.Multiple kinks were observed along the length of the stylet.The component lengths were found to be within manufacturing specifications.It appeared then that the protrusion of the stylet through the catheter valve was caused by manipulation of the stylet within the t-lock assembly.The abundant usage residues suggested that manipulation occurred during use or attempted use.A lot history review (lhr) of reav0700 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the hospital opened a groshong 3cg 5f double lumen picc and the stylet extended through the end of the catheter.The device was not used on a patient.

• Brand Name: GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS)
• 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: 6642367
• MDR Text Key: 77775344
• Report Number: 3006260740-2017-00780
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741107894
• UDI-Public: (01)00801741107894(17)170828(10)REAV0700
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/14/2017

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: 08/28/2017
• Device Model Number: N/A
• Device Catalogue Number: CK000516
• Device Lot Number: REAV0700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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