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

Model Number 788422

Device Problems Expiration Date Error (2528); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

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 customer had an expired bard optima ureteral stent 4.7 into 22 cm.It was stated that the device expired on 19apr2021 and the device was inserted on (b)(6) 2021.

Manufacturer Narrative

The reported event was confirmed as a use related.It was unknown whether the device had met relevant specifications.The root cause for this failure mode was due to the use of an expired product.The device history record review was not required due to the reported issue was confirmed as a use related.Per investigation a labeling review was not required.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.H3 other text : the device was not returned.

Event Description

It was reported that the customer had an expired bard optima ureteral stent 4.7 into 22 cm.It was stated that the device expired on 19apr2021 and the device was inserted on (b)(6) 2021.Per follow up information received from the ibc via email on 09jun2021 it was stated that the bard inlay optima stent 4.7 into 22 cm which was expired by a week or two.The surgeon wanted to use it up so as not to waste and know it was outdated by a short time but the surgeon felt it would not hurt the patient so went ahead.The remaining one which was expired two days ago has been removed.It is not the physician practice to use the outdated products but because the surgeon insisted on using it so went ahead.It was noted that the surgeon wrote to the company to just see whether there were any issues with using a recently outdated product.

• Brand Name: BARD INLAY OPTIMA URETERAL STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11921928
• MDR Text Key: 253780335
• Report Number: 1018233-2021-03187
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741015663
• UDI-Public: (01)00801741015663
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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: 04/19/2021
• Device Model Number: 788422
• Device Catalogue Number: 788422
• Device Lot Number: NGBP0274
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other