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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2023

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.

Event Description

It was reported that contents inside the ureteral stent packaging did not match with the outer labelling.

Manufacturer Narrative

The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿wrong line clearance".However, there was insufficient information to confirm this potential root cause.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "device description: the bard® inlay¿ double pigtail ureteral stent with suture is provided with a hydrophilic (lubricious) coating which aids in stent insertion and enhances patient comfort while indwell-ing and a monofilament suture loop which aids in stent removal.Included are the following items: 1 lubricious double pigtail ureteral stent with suture 1 guidewire (unless ordered without guidewire) 1 push catheter with radiopaque tip 1 pigtail straightener 1 information for use the bard® inlay¿ versafit¿ ureteral stent with suture is provided with a hydrophilic (lubricious) coating which aids in stent insertion and enhances patient comfort while indwelling and a monofilament suture loop which aids in stent removal.The multi-length feature allows the device to be fitted to most ureters (22-32cm).Included are the following items: 1 multi-length lubricious ureteral stent with suture, 1 guidewire (unless ordered without guidewire), 1 push catheter with radiopaque tip, 1 pigtail straightener and 1 information for use".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.

Event Description

It was reported that contents inside the ureteral stent packaging did not match with the outer labelling.

• 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: 18486728
• MDR Text Key: 333039800
• Report Number: 1018233-2024-00073
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 05/28/2024

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: 12/28/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 10/19/2015
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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