MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 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 Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: sample (if available), patient severity, applicable previous investigation(s), complaint and lot history review, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a poor connection in a groshong nxt connector is confirmed and was determined to be manufacturing related.Four 4 fr two-piece groshong nxt connectors and one stiffening stylet with flushing hub attached were returned for evaluation.An initial visual observation showed some use residue on the returned samples.The connectors were returned not assembled, and the blue internal compression sleeve of each distal connector piece appears to have been advanced.A microscopic observation revealed the locking arms of the proximal connector pieces were very slightly damaged.An attempt was made to assemble and then disassemble the connectors.An audible click could be heard when each connector was assembled; however, each connector was found to be able to be pulled apart by hand with some force.The distance between the locking arms of the proximal connector pieces was measured and each was found to be too wide and out of specification.The manufacturing facility was notified of this event, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.A batch history review (bhr) of refx2635 showed four other similar product complaint(s) from this lot number.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the extension tubing had a problem, unable to be engaged.Since there was no spare part available, the catheter was scrapped.No other information was provided.02/17/2023 - the returned samples exhibited damage on the locking arms of the proximal connector.It was reported this occurred with four devices.This report addresses the fourth device.

• 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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16443744
• MDR Text Key: 310337675
• Report Number: 3006260740-2023-00559
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741075261
• UDI-Public: (01)00801741075261
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• 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: REFX2635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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 Outcome(s): Other