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

Catalog Number 777626

Device Problem Wrong Label (4073)

Patient Problem Pain (1994)

Event Date 09/27/2023

Event Type  malfunction  

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.H3 other text : the device was not returned.

Event Description

It was reported that during the operation, upon opening the package, it was found that the physical model specification (6fr.*26cm) of the medical consumables was inconsistent with the model specification on the box, and the physical specification in the box was 4.7f*26cm, which could not be used for the patient, resulting in prolonged operation time and increased pain for the patient.It was unknown what medical intervention was provided.

Event Description

It was reported that during the operation, upon opening the package, it was found that the physical model specification (777626 6fr.*26cm) of the medical consumables was inconsistent with the model specification on the box, and the physical specification in the box was 4.7f*26cm, which could not be used for the patient, resulting in prolonged operation time and increased pain for the patient.The event has occurred once again with the same customer.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be wrong line clearance.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review is not required as it would not have prevented the reported event.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.Retuh3.

• 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: 18030232
• MDR Text Key: 326858833
• Report Number: 1018233-2023-07716
• Device Sequence Number: 1
• Product Code: FAD
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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 Catalogue Number: 777626
• Device Lot Number: NGGY3400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2022
• 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