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

Model Number	788422
Medical Device Problem Codes	Expiration Date Error (2528); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem 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.
Additional 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 or Problem 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4.7 into 22 cm which was expired by a week or two.The surgeon wanted to use it up so as not to waste and know it was outdated by a short time but the surgeon felt it would not hurt the patient so went ahead.The remaining one which was expired two days ago has been removed.It is not the physician practice to use the outdated products but because the surgeon insisted on using it so went ahead.It was noted that the surgeon wrote to the company to just see whether there were any issues with using a recently outdated product.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
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11921928
• Report Number: 1018233-2021-03187
• Device Sequence Number: 3911569
• Product Code: FAD
• UDI-Device Identifier: 00801741015663
• UDI-Public: (01)00801741015663
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other