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 N/A

Device Problem Material Perforation (2205)

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

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recv3447 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that it was found during pre-flushing prior to placement that the guide wire pierced the catheter.No other information was provided.

Manufacturer Narrative

H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter is confirmed and was determined to be use related.One 4 fr single lumen groshong nxt clearvue catheter with stiffening stylet and flushing hub inserted was returned for evaluation.An initial visual observation showed use residue on the returned sample.A hole was observed in the catheter approximately 2.3 cm proximal to the distal tip of the catheter.A microscopic observation revealed a ¿c¿-shaped split in the catheter just proximal to the distal tip of the stylet within the catheter.The surface of the split was observed to be granular in texture.The location, shape, and texture of the damage observed in the returned catheter are indicative of damage caused by the stylet tip; this can be caused by manipulation of the stiffening stylet within the catheter without first flushing the catheter and/or forceful insertion of the stylet and catheter against resistance.A lot history review (lhr) of recv3447 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that it was found during pre-flushing prior to placement that the guide wire pierced the catheter.No other information was provided.

• 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
• MDR Report Key: 8679465
• MDR Text Key: 147456326
• Report Number: 3006260740-2019-01597
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• 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
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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: RECV3447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Event Location: Hospital
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1