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

Model Number	777628
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
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 after opening the package, the product was found to leak air and the pigtail of one end was disconnected from the stent.As per additional information received via email on 28 jul 2020 from ibc representative, the air leak was not a result of disconnect.When opened the packaging box, the user found the first layer of sealed plastic packaging was leaking.
Event or Problem Description
It was reported that after opening the package, the product was found to leak air and the pigtail of one end was disconnected from the stent.As per additional information received via email on 28jul2020 from the ibc representative, the air leak was not a result of disconnect.When opened the package box, the user found the first layer of sealed plastic package was leaking.Per additional information from the ibc representative on 21sept2020, the package air leak was from a different device than the device found to be disconnected.When the doctor noticed the inner package was leaked, it was assumed to no longer be germ free, therefore, the device was not used.
Additional Manufacturer Narrative
The reported event was inconclusive, due to the poor sample condition.Visual inspection noted that one ureteral stent was received.Visual evaluation noted that no package was received.The results of the investigation were inconclusive due to the poor sample condition.A potential root cause for this failure mode could be due to ¿inappropriate package design.¿ the device was not used for the treatment.It was unknown whether the product had caused the reported failure.It was unknown whether the device had met specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed because the labeling could not have prevented the reported failure.

• Brand Name: BARD INLAY URETERAL STENT WITH HYDROGLIDE GUIDEWIRE
• Common Device Name: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10352280
• Report Number: 1018233-2020-04912
• Device Sequence Number: 2842723
• Product Code: FAD
• UDI-Device Identifier: 10801741014564
• UDI-Public: (01)10801741014564
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 11/07/2023
• Device Model Number: 777628
• Device Catalogue Number: 777628
• Device Lot Number: NGDQ3233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1