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

Model Number 7655405

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 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of recu2723 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the connector detached and fluid leaks occurred after reconnection.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 hub detachment is confirmed but the exact cause remains unknown.One photo sample of a 4 fr groshong nxt connector was provided for evaluation.The two-piece connector is shown to be assembled with the catheter.The catheter appears to have been trimmed.The red hub is detached from the white compression sleeve and extension tubing.The characteristics of the components could not be clearly inspected from the image provided.Based on the description of the reported event and photo provided, possible contributing factors include tensile damage and excessive manipulation of the connector.Since the hub was shown to be detached, the complaint is confirmed but the exact contributing factors remain unknown.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the connector detached and fluid leaks occurred after reconnection.No other information was provided.

• Brand Name: GROSHONG NXT CLEARVUE 4F SL
• 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: 11023782
• MDR Text Key: 222321583
• Report Number: 3006260740-2020-20959
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7655405
• Device Catalogue Number: 7655405
• Device Lot Number: RECU2723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other