MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SL WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 7617405

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redu2456 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(4).Device not returned for evaluation.

Event Description

It was reported that when maintaining the catheter 1 month after placement, the nurse found that the extension tube detached spontaneously.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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a break in the catheter was confirmed but the cause is unknown.A photo of a proximal section of a 4fr s/l groshong nxt catheter was returned for evaluation of this complaint.The catheter contained the proximal connector (luer adaptor, extension leg and molded suture hub) and the distal connector.None of the catheter shaft was visible in the picture.It is unknown if the catheter shaft dislodged from the two-piece connector or if the tubing broke within the two-piece connector but is not visible in the photo.Without the physical sample, the exact location of the failure could not be established, and the microscopic and dimensional analysis could not be conducted.Therefore, the exact root cause could not be determined at this time.Based on the description of the reported event and evaluation of the photo, possible contributing factors include misassembled or improper connection, tensile (pulling) forces, over-pressurization or material fatigue.

Event Description

It was reported that when maintaining the catheter 1 month after placement, the nurse found that the extension tube detached spontaneously.No other information was provided.

• Brand Name: GROSHONG NXT CLEARVUE 4F SL 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
• MDR Report Key: 11029506
• MDR Text Key: 222661642
• Report Number: 3006260740-2020-20994
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7617405
• Device Catalogue Number: 7617405
• Device Lot Number: REDU2456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR