MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CARESITE®; SET, ADMINISTRATION, INTRA

Catalog Number	354207
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Syncope/Fainting (4411)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: brief inquiry description: blood back flow, leaking.Detailed inquiry description: from customer: iv tubing used was the braun 0.2 line lot 0061829317 and braun flow regulator set lot 221501l.Patient was connected to iv line post iv insertion, blood flowed back up the tubing (tourniquet was off), and then continued to leak out of tubing.Patient was disconnected and i connected them to a saline lock which i luckily had right beside me.Patient did go vasovagal with light headiness, and looked slightly pale.I believe the leak was with the iv tubing and not flow regulator but i could not exactly pinpoint at what site.My first thought when i noticed the blood flow return was the connection was loose but when i tightened it continued to flow upwards then started leaking.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) was submitted to the manufacturer for evaluation.Through visual examination, no defects or damages were observed.The sample was functionally leak tested per specification and no leakages were noted, other than from the filter vent hole located on the set which is per specification.The sample was piggyback tested in an attempt to replicate the defect of backflow with no defect observed.Five (5) retain samples with the same lot number were also tested per specification with passing results and no leakage observed.A review of the non-conformance system database was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.Based on the investigation, the reported defect could not be observed/replicated.The sample was within specification.The complaint is not confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: CARESITE®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18208444
• Report Number: 2523676-2023-00752
• Device Sequence Number: 7345623
• Product Code: FPA
• UDI-Device Identifier: 04046964182136
• UDI-Public: (01)04046964182136
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 354207
• Device Lot Number: 0061829317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• 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