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

Model Number	788800
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
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.The device was not returned.
Event or Problem Description
It was reported that the hospital staff found that the sterile package was not fully sealed upon removing from the box.
Event or Problem Description
It was reported that hospital staff found that the sterile packaging was not fully sealed upon removing from the box.
Additional Manufacturer Narrative
The reported event could not be confirmed due to poor sample condition.Visual inspection noted one photo sample was received.Visual evaluation noted the photo shows an inlay optima stent outside the box packaging but still inside the plastic inner packaging.The photo does not provide enough evidence of an open or gap in the seal at any location, and appears to be sealed.The results of the investigation were inconclusive due to poor sample condition.A potential root cause for the reported failure could be incorrect sealing operation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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 OPTIMA MULTILENGTH URETERAL STENT
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11262541
• Report Number: 1018233-2021-00207
• Device Sequence Number: 11781695
• Product Code: FAD
• UDI-Device Identifier: 00801741015878
• UDI-Public: (01)00801741015878
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: Other
• Device Expiration Date: 04/04/2022
• Device Model Number: 788800
• Device Catalogue Number: 788800
• Device Lot Number: NGCP2006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 07/02/2021
• 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