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

Model Number	NF1330
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)(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: event 2: end user reports, "we are having issues with our t-port connectors for iv tubing.They are cracking and leaking.Samples have blood on them from the leakage.This can lead to potential infection and also loss of ivf to the patient." no injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 2: three (3) physical samples without packaging were provided for evaluation.The sets were decontaminated and functionally leak tested.During testing it was noted that the connector was cracked where the caresite valve is connected.It was determined that the leakage was occurring from the filter.The sample and all available information were forwarded to the supplier to investigate.An investigation by supplier determined that the leakage was present from the noted crack in the female luer conector.During the suppliers investigation the sample was also found to be fragile, and the crack is in the weakest area of the part.Unfortunately, without having any more batch information it is not possible to perform any batch review to identify events during the molding process that could have generated the weakness.However, the supplier does not have any record of parts with female luer cone out of spec in the database of our internal nonconformities.While we are unable to confirm the possible cause of the reported defect, 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: SAFELINE®
• 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: 12419046
• Report Number: 2523676-2021-00293
• Device Sequence Number: 3602060
• Product Code: FPA
• UDI-Device Identifier: 04046964187247
• UDI-Public: 04046964187247
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K931377
• 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 Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: NF1330
• Device Catalogue Number: NF1330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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