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

Model Number 788800

Device Problem Unsealed Device Packaging (1444)

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

Event Date 01/08/2021

Event Type  malfunction  

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 Description

It was reported that the hospital staff found that the sterile package was not fully sealed upon removing from the box.

Event Description

It was reported that hospital staff found that the sterile packaging was not fully sealed upon removing from the box.

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
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11262541
• MDR Text Key: 229813028
• Report Number: 1018233-2021-00207
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741015878
• UDI-Public: (01)00801741015878
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other