MAUDE Adverse Event Report: BD CARIBE LTD. TRAY BONANNO CATHETER S/SU; SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES

Model Number 408289

Device Problem Break (1069)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that tray bonanno catheter s/su catheter broke apart.The following information was provided by the initial reporter: reason for complaint: the metal inside (needle) of the catheter was very stiff to re insert back into the catheter prior to being inserted.Then when the needle pushed back into catheter the end 3 or 4 cms of the catheter came off.

• Brand Name: TRAY BONANNO CATHETER S/SU
• Type of Device: SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES
• 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: 11388571
• MDR Text Key: 246690337
• Report Number: 2618282-2021-00015
• Device Sequence Number: 1
• Product Code: FEZ
• UDI-Device Identifier: 00382904082895
• UDI-Public: 00382904082895
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 408289
• Device Catalogue Number: 408289
• Device Lot Number: 0013214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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