MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD INLAY URETERAL STENT

Model Number 778426

Device Problems Break (1069); Disconnection (1171); Material Fragmentation (1261)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the ureteral stent was broken after opening the package.Per follow up via email on 22jul2020, the stent was broken within the package.Per follow up on 3nov2020, the stent was found to be disconnected after the user opened the packaging.The doctor cut the suture off and discarded it.

Event Description

It was reported that the ureteral stent was broken after opening the package.Per follow up via email on 22jul2020, the stent was broken within the package.Per follow up on 03nov2020, the stent was found to be disconnected after the user opened the packaging.The doctor cut the suture off and discarded it.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.A disconnected stent was returned with its original packaging.The perforated bag in which the stent was shipped in was not returned.The pigtail was disconnected from the rest of the stent and location of the disconnect was not at ported hole.The stent od and tip id measured 0.062" which was within specifications.According to the supplier evaluation, it was unknown the reported event cause is unknown, however, supplier have taken steps to further ensure stents are not shipped "broken", including an additional tensile testing an increase in sample sizes.A potential root cause of the event could be due to "inappropriate package design".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: "not use if the package or product is damaged.Improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period." h11:section a through f - the information provided by bd 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 bd.

• Brand Name: BARD INLAY URETERAL STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10830021
• MDR Text Key: 223454949
• Report Number: 1018233-2020-06346
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014765
• UDI-Public: (01)00801741014765
• Combination Product (y/n): N
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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: 11/03/2020
• Device Model Number: 778426
• Device Catalogue Number: 778426
• Device Lot Number: NGAT4833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1