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

Model Number	786426
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.No physical sample was returned, however, six photo samples were submitted.A potential root causes for this event could be, "multiple tally in the station during the label printing, typo error".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: "warning: after use, this product may use be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable laws and regulations.".
Event or Problem Description
It was reported that the package of 786426 ureteral stent was not opened.The size of the stent inside was 6fr.There were a total of 6 stents.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.No physical sample was returned, however, six photo samples were submitted.Photo 1 shows the stent within the packaging with lot nggv4106 and the size listed as 4.7 fr with an additional stent outside the packaging with 4.7 fr printed.The stent within the packaging appeared to be slightly larger in size, however, as the physical sample as not returned, unable to verify if the size was within specifications.Photo 2 shows the packages of six individual stents all from lot nggv4106 with size 4.7 fr listed.Photos 3 and 4 show the stent within the packaging, 6 f was noted to be printed on the body of the stent.Photos 5, 6, and 7 show the overview of 2 stent packages again with the same lot and 4.7 fr listed.As the physical sample was not returned for evaluation unable to determine the cause of the discrepancy as it could potentially be supplier or packaging related.As no patient involvement was reported the device the device was not used for treatment.It is unknown if the device had met all relevant specifications.Though a specific cause cannot be determined, based on the risk document potential root causes for this event could be, "multiple tally in the station during the label printing, typo error".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: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent." "care should be exercised when removing the stent from the inner polybag to eliminate 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.H3 other text: the actual/suspected device was evaluated.
Event or Problem Description
It was reported that the package of 786426 ureteral stent was not opened.The size of the stent inside was 6fr.There were a total of 6 stents.
Additional Manufacturer Narrative
The reported event was confirmed, packaging related.Six photo samples were submitted.The six unopened ureteral stents were returned.Visual evaluation of the physical sample noted 4.7 fr.X 26cm marked on the packaging and 6f x 26 cm marked on the product.As there is a discrepancy between the product packaging and device, which is out of specifications per, "all components shall be present and correct." using a french gauge, the stent was confirmed to be 6fr.The outer diameter was found to measure 0.079" for five of the six samples, with sample 3 measuring 0.0785".A potential root cause for this event could be, "wrong line clearance".As no patient involvement was reported the device was not used for treatment.It is unknown if the device had met all relevant specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling/packaging 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 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the package of 786426 ureteral stent was not opened.The size of the stent inside was 6fr.There were a total of 6 stents.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ 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: 16731621
• Report Number: 1018233-2023-02515
• Device Sequence Number: 6673652
• Product Code: FAD
• UDI-Device Identifier: 10801741015042
• UDI-Public: (01)10801741015042
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2023

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: 09/24/2024
• Device Model Number: 786426
• Device Catalogue Number: 786426
• Device Lot Number: NGGV4106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/17/2023; 07/19/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/26/2023; 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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