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

Model Number	408289
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot#: batch 105452 does not exist for material number 408289.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the tray bonanno catheter s/su, the device experienced the catheter breaking apart.The following information was provided by the initial reporter.The customer stated: plastic sheath around the needle seems to be torn.
Event or Problem Description
It was reported when using the tray bonanno catheter s/su, the device experienced the catheter breaking apart.The following information was provided by the initial reporter.The customer stated: plastic sheath around the needle seems to be torn.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 9/23/2021 h.6.Investigation: based on the sample provided to bd for evaluation, the reported condition was verified.A potential root cause was also identified with sample evidence showing the catheter sleeve may not have been positioned correctly.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.A review of the device history record was performed, and no quality issues were found during production.Potential root cause can be directed to possible handling issues based on the evaluation of the sample received.As per complaint sample evidence has a notable tore at the end of the catheter in which could be an indicative that the catheter sleeve was not positioned correctly.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as dir 10000690801.This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: bonnano.Device failure: catheter damaged / defective.
Event or Problem Description
No additional information.

• Brand Name: TRAY BONANNO CATHETER S/SU
• Common Device Name: SUPRAPUBIC UROLOGICAL CATHETER ACCES.
• 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: 12450355
• Report Number: 2618282-2021-00053
• Device Sequence Number: 5003267
• Product Code: FEZ
• UDI-Device Identifier: 00382904082895
• UDI-Public: 00382904082895
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2025

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 Model Number: 408289
• Device Catalogue Number: 408289
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 10/15/2021; Not provided
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 11/09/2021; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown