MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Model Number	777624
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that the catheter placement was performed in this patient with calculi for drainage on may 16.Once the package was opened, the ureteral stent was found to be ruptured.The catheter was not used and was replaced with another product for catheter placement, causing no impact on the patient.
Event or Problem Description
It was reported that the catheter placement was performed in this patient with calculi for drainage on (b)(6).Once the package was opened, the ureteral stent was found to be ruptured.The catheter was not used and was replaced with another product for catheter placement, causing no impact on the patient.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted received 2 photo samples.First photos shows outer packaging of stent.Second photo sample shows top view of ureteral stent within plastic packaging.Bottom right corner of photo sample shows damaged pigtails.Therefore, product does not meet specifications.Although an exact root cause could not be determined, a potential root cause could be inappropriate package design.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "precautions: for single use only.Do not resterilize.Do not use if the package or product is damaged.Improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period." 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.H3 other text: the actual/suspected device was inspected.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Common Device Name: URETERAL STENT
• 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: 17098280
• Report Number: 1018233-2023-04171
• Device Sequence Number: 1868668
• Product Code: FAD
• UDI-Device Identifier: 10801741014540
• UDI-Public: (01)10801741014540
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2026
• Device Model Number: 777624
• Device Catalogue Number: 777624
• Device Lot Number: NGFZ2073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown