MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URETERAL STENTS

Device Problem Flaked (1246)

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

Event Date 09/13/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, during use at the hospital, the guide wire was found unsmooth and the coating flaked off.Based upon the notification received on (b)(6) 2023, a sample was received on (b)(6) 2023 and the customer did not return guidewire but returned a ureteral stent.

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 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.

Manufacturer Narrative

The reported event is inconclusive due to the condition of the sample received.Visual evaluation noted visual requirements per cs-xx state to use unaided eye at 12" to 18" distance under normal room lighting unless otherwise noted.When performing the visual inspection it could be seen that a separation was located on the proximal pigtail.No flaking of the sample could be confirmed.The sample was smooth to the touch with no voids or bumps.The flaking reported in the complaint could not be confirmed.The part and lot number were not provided for a dhr review.Although an exact root cause could not be determined a potential root cause could be inadequate material.The lot number is unknown; therefore, the device history record could not be reviewed.The labelling review is not required as the product catalog number is unknown.H11: 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

It was reported that on june 12, during use at the hospital, the guide wire was found unsmooth and the coating flaked off.Based upon the notification received on 13sep2023, a sample was received on 13sep2023 and the customer did not return guidewire but returned a ureteral stent.

• Brand Name: URETERAL STENTS
• Type of Device: URETERAL STENTS
• 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: 17894231
• MDR Text Key: 325389121
• Report Number: 1018233-2023-07236
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 12/21/2023
• 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