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

Catalog Number	352905
Medical Device Problem Code	Leak/Splash (1354)
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)(6).One used sample in open packaging and 126 unused samples in original packaging were provided for evaluation.All samples were visually evaluated, and no defects were observed.As per aql 80 samples were leak tested and leakage was detected at the bonded joint of the female luer lock connector and safeday valve.Further investigation revealed insufficient solvent at the bonded joint.Leakage was not identified on the other 79 unused samples tested.Based on the evaluation results, the reported defect was confirmed.Incidents of this nature are attributed to operator oversight during the manual solvent application process of the product.The operator applied insufficient solvent on the tubing during the bonding process.Although our training procedures ensure that our employees are properly trained in their areas of responsibility, an oversight on the operator's part can be attributed to an incident of this nature.Retained units were evaluated and passed the internal testing.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.Note: the original initial mdr for this case was inadvertently submitted via the "test" account of the fda electronic submission gateway (esg) webtrader.As the original submission was not submitted through the "production" account of the fda esg webtrader, a new initial mdr submission is required per zoom call with (b)(6) of the fda esg help desk.
Event or Problem Description
As reported, event 1: recently we have had at least three instances where our j-loops for iv's, safeday extension set ref 352905 lot 0061938553 have been leaking from the connection to the clave.These extension sets are sometimes used with patients who are receiving chemotherapy.

• Brand Name: SAFEDAY¿
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km 22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20427291
• Report Number: 2523676-2024-00818
• Device Sequence Number: 15350801
• Product Code: FPA
• UDI-Device Identifier: 04046955678129
• UDI-Public: (01)04046955678129
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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 Catalogue Number: 352905
• Device Lot Number: 0061938553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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