MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number 7B3062

Device Problems Detachment of Device or Device Component (2907); Free or Unrestricted Flow (2945)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).As reported by the end customer, samples are not available for evaluation.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: "when the clamp is moved up the tubing, the clamp is getting stuck.When the surgeon tries to move it, the blue roller portion on clamp falls off.".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No samples were provided for evalutaion.Without the actual device, a thorough investigation could not be performed.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow-up will be submitted.

• Brand Name: IRRIGATION SET
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown,
• MDR Report Key: 9977902
• MDR Text Key: 190060923
• Report Number: 2523676-2020-00104
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7B3062
• Device Lot Number: 0061705040
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1