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

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the representative received a report from one of their distributors regarding double j catheter, where one catheter was expelled by the patient, another migrated and the patient was able to remove it and the third migrated to another region of the body and the doctor had to intervene to remove it.There was no major damage to patients.Per follow-up information received from ibc on 30mar2023, stated that no medical or surgical intervention required due to the incident.

Event Description

It was reported that the representative received a report from one of their distributors regarding double j catheter, where one catheter was expelled by the patient, another migrated and the patient was able to remove it and the third migrated to another region of the body and the doctor had to intervene to remove it.There was no major damage to patients.Per follow-up information received from ibc on 30mar2023, stated that no medical or surgical intervention required due to the incident.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "material selection part geometry".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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.

• 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: 16732345
• MDR Text Key: 313259651
• Report Number: 1018233-2023-02529
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/21/2023
• 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