MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIG JAPAN HANG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Misassembled (1398); Detachment of Device or Device Component (2907)

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

Event Date 11/25/2022

Event Type  malfunction  

Event Description

It was reported that the patient had a groshong catheter implanted on (b)(6) 2022.On (b)(6) 2022, the catheter connector was detached from the catheter connection.There was no reported patient injury.No other information was provided.

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the patient had a groshong catheter implanted on (b)(6) 2022.On (b)(6) 2022, the catheter connector was detached from the catheter connection.There was no reported patient injury.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 analysis, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken catheter is confirmed and was determined to be related to a tensile break and initial assembly of the device.One 4 fr nxt clearvue groshong catheter and a two-piece connector was returned for evaluation.An initial visual observation showed use residues throughout the catheter, and the catheter appeared broken at the 45 cm depth marker with an uneven fracture surface.The two-piece connector was returned assembled; however, the catheter was not attached.A broken segment of the catheter was visible inside the compression sleeve of the distal piece of the two-piece connector.A tactile evaluation of the device revealed tensile weakness around the proximal end of the catheter where it was broken.A microscopic observation revealed the uneven break in the catheter had a granular fracture surface on the blue half of the break and a smooth fracture surface on the clear half of the break.The distal piece of the two-piece connector was removed from the proximal piece of the connector, and it was revealed there was an additional broken piece on the metal cannula of the proximal connector piece.The fracture surface of this piece appeared granular as well.The distal piece was cut in half to reveal the compression sleeve advanced farther than it is designed, squeezing the remaining fragment of catheter.After evaluation of the returned device, the complaint of a broken catheter is confirmed.During assembly of the catheter with the two-piece connector, it is possible to advance the catheter too far onto the metal segment of the proximal piece of the connector, causing the catheter to bunch on the metal piece.If the catheter is bunched, the distal piece of the connector will be more difficult to lock into place, which may cause the compression sleeve to advance farther than designed.The compression sleeve will squeeze the catheter too tightly causing difficulties with infusion and making the catheter difficult to disassemble if desired.

• Brand Name: GROSHONG NXT WITH STRIPED CATH 4F SINGLE LUMEN BASIG JAPAN HANG
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16036317
• MDR Text Key: 308164921
• Report Number: 3006260740-2022-05818
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

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 Model Number: N/A
• Device Catalogue Number: 7617405J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 02/24/2023
• 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
• Patient Outcome(s): Other