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

Model Number 408289

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/12/2021

Event Type  malfunction  

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 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 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.

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.

• Brand Name: TRAY BONANNO CATHETER S/SU
• Type of Device: 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
• MDR Text Key: 271308155
• Report Number: 2618282-2021-00053
• Device Sequence Number: 1
• Product Code: FEZ
• UDI-Device Identifier: 00382904082895
• UDI-Public: 00382904082895
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: PREAMENDMENT
• 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,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 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
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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