MAUDE Adverse Event Report: BD CARIBE LTD. BD BONNANO¿ CATHETER; SUPRAPUBIC UROLOGICAL CATHETER

Model Number 408289

Device Problem Defective Device (2588)

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

Event Date 10/22/2021

Event Type  malfunction  

Event Description

It was reported bd bonnano¿ catheter was deformed.The following information was provided by the initial reporter: "it was reported that the dr was preparing and testing catheter as routine prior to insertion and noticed an abnormal resistance when sliding needle over catheter compared to the usual feel with these devices.He felt it was not appropriate to proceed and used another device without this issue.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: after evaluation of provided sample, the reported failure could not be confirmed.A review of the device history record was performed, and no quality issues were found during production.The manufacturing facility has been notified of this incident and no discrepancy or non-conformance were identified that could have contributed to the reported condition.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD BONNANO¿ CATHETER
• Type of Device: SUPRAPUBIC UROLOGICAL CATHETER
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12849310
• MDR Text Key: 285743335
• Report Number: 2618282-2021-00068
• Device Sequence Number: 1
• Product Code: FEZ
• UDI-Device Identifier: 00382904082895
• UDI-Public: 00382904082895
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 408289
• Device Catalogue Number: 408289
• Device Lot Number: 1060646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• 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