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

Catalog Number 777626

Device Problem Wrong Label (4073)

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

It was reported that after investigation, there were 15 sets of 777626 in the dealer's warehouse where the packaging did not match with the actual product inside, which were 4.7fr brackets.Per additional information via email from ibc on 14nov2023, the package includes a nitinol guidewire and a 4.7fr bracket.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that after investigation, there were (b)(4) sets of (b)(6) in the dealer's warehouse where the packaging did not match with the actual product inside, which were 4.7fr brackets.Per additional information via email from ibc on 14nov2023, the package includes a nitinol guidewire and a 4.7fr bracket.

Manufacturer Narrative

The reported event is confirmed.Visual evaluation noted received (b)(4)ureteral stents in original closed packaging.Upon unpacking samples it was found in all returned samples that the contained incorrect stent size of 4.7 fr x 26 cm was packaged.Also received 2photo samples.First photo sample shows close up of pcn and expiration date.Second photo sample shows top view of 15 stent kits laid out in original closed packaging.Based on physical sample received product does not meet specifications.The root cause is product mix potentially occurred during an incorrectly segregated and returned material process in combination with a poorly performed line release.Labeling review, and dhr review are not required.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® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18220463
• MDR Text Key: 330245843
• Report Number: 1018233-2023-08600
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014557
• UDI-Public: (01)10801741014557
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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 Catalogue Number: 777626
• Device Lot Number: NGGY3400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other