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

Model Number	788624
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2023
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.
Event or Problem Description
It was reported that the package of ureteral stent was found to be not sealed.
Event or Problem Description
It was reported that the package of ureteral stent was found to be not sealed.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The ureteral stent with push catheter was returned in the original packaging.A tear, appearing to be caused by a sharp object was noted in the plastic sleeve covering the ureteral stent, this is out of specifications.As it is unknown when or how this tear occurred, this event will be confirmed, cause unknown.Though a specific cause cannot be determined, based on the risk document a potential root cause for this event could be, "sharps (external or internal)".As no patient involvement was reported, the device was not used, however is intended for treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.Correction: d.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 OPTIMA® URETERAL STENT
• 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: 16527265
• Report Number: 1018233-2023-01653
• Device Sequence Number: 2645784
• Product Code: FAD
• UDI-Device Identifier: 00801741015755
• UDI-Public: (01)00801741015755
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K043193
• 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): 06/11/2023

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: 06/29/2026
• Device Model Number: 788624
• Device Catalogue Number: 788624
• Device Lot Number: NGFZ2774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 03/12/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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