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

Catalog Number 787626

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/12/2018

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 there was a hair found on the product prior to use.Per photos received on (b)(6) 2018, there was a hair found inside the packaging.

Event Description

It was reported that there was a hair found on the product prior to use.Per photos received on 3-oct-18, there was a hair found inside the packaging.

Manufacturer Narrative

The reported issue was confirmed.The device was returned for evaluation.Visual inspection observed loose foreign material (hair) inside the unopened package.Sample was examined under microscopic and identified this to be related to manufacturing.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.The instructions for use were found adequate and 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.".

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7966110
• MDR Text Key: 123851058
• Report Number: 1018233-2018-04748
• 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: 12/17/2018

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: 06/01/2021
• Device Catalogue Number: 787626
• Device Lot Number: MYCTTD78
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 12/15/2018
• Supplement Dates FDA Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1