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

Model Number 777426

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/11/2023

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 white grease was observed upon unpacking of the ureteral stent.The surgery time was delayed and surgery schedule by health care professional was affected.

Event Description

It was reported that white grease was observed upon unpacking of the ureteral stent.The surgery time was delayed and surgery schedule by health care professional was affected.

Manufacturer Narrative

The reported event is confirmed, cause unknown.A photo sample was was submitted.The ureteral stent was returned in the opened original packaging along with an empty guidewire packaging.An evaluation of the stent was completed.Visual evaluation of the photo sample noted a white substance on the surface of the guidewire, unable to identify the substance without the physical sample.Visual evaluation of the ureteral stent noted no foreign material or defect.As the guidewire was not returned, this event will be confirmed based on the photo sample.Though a specific cause cannot be determined, a potential root cause for this event could be, "not follow inspection procedure".No manufacturing issues or non-conformances were noted during review of the dhr 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.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
• Type of Device: 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: 16663005
• MDR Text Key: 312512925
• Report Number: 1018233-2023-02243
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014489
• UDI-Public: (01)10801741014489
• 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: 05/31/2023

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
• Device Model Number: 777426
• Device Catalogue Number: 777426
• Device Lot Number: NGGV2067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• 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