MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Component Incompatible (1108); Difficult to Insert (1316)

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

It was reported that client states that when they were trying slide the oversleeve onto the catheter it wasn¿t passing through.After trying hard, they were managed to pass the catheter, but the tip of the oversleeve¿s silicon part was getting folded inside.Client also states that when they are trying to connect the extension leg and oversleeve , catheter inside the oversleeve is also getting kinked.Patient status: admitted.

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refw0195 showed six other similar product complaint(s) from this lot number.

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 batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty assembling the catheter to the two-piece connector resulting in catheter kinking and folding of the strain relief was confirmed but the cause is unknown.A video of a 4fr s/l groshong nxt catheter was returned for evaluation.The catheter shaft had previously been assembled onto the two-piece connector.The catheter shaft was seen bunched within the clear strain relief.In addition, the clear strain relief was seen folded inward upon itself.As the user applied axial tensile stresses on the catheter shaft, the bunching in the catheter and folded strain relief appeared to relax and straighten out.It appears that the difficult connection led to the catheter bunching and strain relief damage.However, the cause of the difficult connection could not be determined from the returned video.Dimensional analysis, tactile evaluation, and functional testing could not be conducted without the physical sample.Possible contributing factors could include mechanical interference, a damaged catheter/connector, or assembly technique.A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.The ifu instructs the user, ¿retrieve the oversleeve portion of the connector and advance it over the end of the catheter.If you feel some resistance while advancing the oversleeve, gently twist back and forth or spin to ease its passage over the catheter.Gently advance the catheter onto the connector blunt until it butts up against the colored plastic body.The catheter should lie flat on the blunt without any kinks.¿.

Event Description

It was reported that client states that when they were trying slide the oversleeve onto the catheter it wasn¿t passing through.After trying hard, they were managed to pass the catheter, but the tip of the oversleeve¿s silicon part was getting folded inside.Client also states that when they are trying to connect the extension leg and oversleeve , catheter inside the oversleeve is also getting kinked.Patient status: admitted.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13977937
• MDR Text Key: 288476302
• Report Number: 3006260740-2022-01079
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• 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: 7655405
• Device Lot Number: REFW0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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