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

Model Number	313003
Medical Device Problem Codes	Break (1069); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: it was reported that when assessing the patient and cbi the rn noticed that there was something in the tubing, when she pinched it she realized it was hard, not sediment.The cbi was stopped, tubing disconnected, and flushed.The particle of plastic was the tip off the spike.New tubing was used to continue cbi.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) photos were provided for evaluation.Upon visual inspection of the photos, it was noted that the first photo depicted a spike that was not listed on the drawing for the reported item number.The second photo was visually inspected with passing results, as no defects were noted.As the item pictured is different than the reported item number, the exact root cause of the reported defect could not be determined.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available, a follow-up will be submitted.

• Brand Name: IRRIGATION SET
• Common Device Name: SYSTEM, IRRIGATION, UROLOG
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 10592463
• Report Number: 2523676-2020-00271
• Device Sequence Number: 10855688
• Product Code: LJH
• UDI-Device Identifier: 04046964175794
• UDI-Public: 04046964175794
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: Health Professional
• Device Model Number: 313003
• Device Catalogue Number: 313003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1