MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	471959
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 event 2 of b.Braun medical internal report number (b)(4).As reported by the user facility, no samples are available for further evaluation.Without the actual device and lot number, a thorough investigation could not be performed.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.
Event or Problem Description
Event 2: as reported by the user facility: "cracking is happening when sodium bicarbonate iv fluids are infusing for long durations of time.We utilize sodium bicarbonate fluids for long duration of time, depending on the patients' urine ph when we administer our high dose methotrexate chemotherapy regimen.We have also had issues with leur locks cracking with infusion of sodium bicarbonate.".

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• MDR Report Key: 10969358
• Report Number: 2523676-2020-00345
• Device Sequence Number: 11002845
• Product Code: FPA
• UDI-Device Identifier: 04046964184512
• UDI-Public: 04046964184512
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 471959
• Device Catalogue Number: 471959
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1