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

Model Number N/A

Device Problems Suction Problem (2170); Failure to Infuse (2340)

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

Event Date 11/01/2021

Event Type  malfunction  

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It was reported that the valve cannot be withdrawn and infused with fluids.No other information was provided.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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of unable to aspirate was confirmed but the exact cause was unknown.The product returned for evaluation was one 4 fr groshong nxt catheter.Microscopic examination of the valve cut was unremarkable and the valve length was measured to be within specification.No potential cause for valve malfunction was observed during microscopic examination.Repeated functional flow tests of the catheter concluded that the groshong valve did not open for aspiration as intended.Infusion tests were successful but the catheter would not aspirate.Following initial valve aspiration testing, the valve was re-lubricated with silicone oil and additional aspiration testing confirmed aspiration.Because application of silicone lubricant established proper valve function, it is reasonable to conclude that a lack of lubricant contributed to the reported event.It is unknown if the lubricant applied during manufacture was affected by the clinical procedure or if the lubricant was affected prior to attempted device use.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the valve cannot be withdrawn and infused with fluids.No other information was provided.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15255293
• MDR Text Key: 305180056
• Report Number: 3006260740-2022-03222
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

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: 7617405
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 09/30/2022
• 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