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

Catalog Number 786626

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the bottom of the sterile package of the tiger tail catheter was not sealed.The device was dropped on the floor as the user picked it from the package.

Event Description

It was reported that the bottom of the sterile package of the tiger tail catheter was not sealed.The device was dropped on the floor as the user picked it from the package.

Manufacturer Narrative

Received only tiger tail in opened package.The reported event was confirmed as manufacturer related.Per visual inspection, the pouch was not sealed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "1) do nor forcibly inserter remove the stent.It may injure patient or/and damage this product.2) avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent.3) avoid contact with sharp edges as this may cause damage to the stent.If grasping device is used, the stent should be removed from ureter first.Tearing of the stent can be caused by sharp instruments.4) determine the proper stent length for the patient.Selection of too short a stent may result in migration.5) in the event of stent migration, cystoscopy or ureteroscopy should be used to return the stent to the original position or remove from patient body.6) any signs of infection in the location of the stent placement require removal of the stent.After checking the condition of the patient, a new should be placed.7) care should be exercised when removing the stent to eliminate tearing or fragmentation." 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.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH NICORE¿ GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7295203
• MDR Text Key: 101121595
• Report Number: 1018233-2018-00555
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 786626
• Device Lot Number: MYBWT990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/25/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1