MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AQUAGUIDE® URETERAL ACCESS SHEATH

Model Number 131135

Device Problem Inability to Irrigate (1337)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported that in an online survey a physician stated no to the question when they were asked if they were able to successfully inject fluids.The physician was not able to successfully inject fluids because unknown in relation to 131135 ¿ aquaguide ureteral access sheath ¿dilator 10fr/sheath diameter 12/14fr, length 35cm.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be material selection/ part geometry of luer.A dhr review is not required as no lot number was reported for this investigation.The instructions for use were found adequate and state the following: "directions for use: only physicians trained in use of endoscopic equipment should use this device.A variety of techniques may be employed; however, the physician should use the technique most appropriate for the individual patient¿s situation." section a through f - the information provided by bd represents all 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.

Event Description

Critical care nurses reported in an online survey that no to the question when they were asked if they were able to successfully inject fluids.The physician was not able to successfully inject fluids because unknown in relation to 131135 - aquaguide® ureteral access sheath ¿dilator 10fr/sheath diameter 12/14fr, length 35cm.

• Brand Name: AQUAGUIDE® URETERAL ACCESS SHEATH
• Type of Device: URETERAL ACCESS SHEATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17349309
• MDR Text Key: 319672469
• Report Number: 1018233-2023-05268
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 00801741052569
• UDI-Public: (01)00801741052569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131135
• Device Catalogue Number: 131135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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