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

Model Number	408289
Medical Device Problem Code	Break (1069)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SUPRAPUBIC UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 11388571
• Report Number: 2618282-2021-00015
• Device Sequence Number: 3513300
• Product Code: FEZ
• UDI-Device Identifier: 00382904082895
• UDI-Public: 00382904082895
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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
• Operator of Device: Other
• Device Expiration Date: 12/31/2024
• Device Model Number: 408289
• Device Catalogue Number: 408289
• Device Lot Number: 0013214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1