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	10/12/2021
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.
Event or Problem Description
It was reported that the ureteral stent broke and the coil separated from the straight site after opening the package.
Event or Problem Description
It was reported that the ureteral stent broke and the coil separated from the straight site after opening the package.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.A photo sample was submitted by the customer which shows a break in the stent by the pigtail.The ureteral stent was returned in the opened original packaging.An evaluation of the physical sample was completed by futurematrix.A potential root cause for the reported event could be, "inappropriate package design".As no patient involvement was reported, the device was not used, however, it is intended for treatment purposes.As damage was noted on the device, it appears to have contributed to the reported event.No manufacturing issues or non-conformances were noted in the dhr review that could have caused or contributed to the reported event.Based on the results of the investigation, no additional action is required at this time.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: "improper handling technique can seriously weaken the stent." "exercise care.Tearing of the stent can be caused by sharp instruments." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." 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.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12746675
• Report Number: 1018233-2021-06923
• Device Sequence Number: 4479939
• Product Code: FAD
• UDI-Device Identifier: 10801741014540
• UDI-Public: (01)10801741014540
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2025
• Device Model Number: 777624
• Device Catalogue Number: 777624
• Device Lot Number: NGEY2203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2021
• 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