MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. STEADYCARE¿; SET, ADMINISTRATION, INTRA

Model Number	470185
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
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 during use, the valve part and the tube part came off and a blood leak occurred.Possible lot numbers: lot number; 0061781769; expiry date 05/05/2024; production date 05/05/2021.Lot number; 0061796024; expiry date 08/23/2024; production date 08/23/2021.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was provided for evaluation.Visual evaluation was done on the sample and it was noted solvent was present, however, it easily unscrewed from the valve as per drawing it should be bonded.Sample failed specifications therefore defect is confirmed.Incidents of this nature are attributed to operator oversight during the assembly of the product.Although our training procedures ensure that all our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.A review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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: STEADYCARE¿
• 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: 14030735
• Report Number: 2523676-2022-00131
• Device Sequence Number: 4610044
• Product Code: FPA
• UDI-Device Identifier: 04046964723995
• UDI-Public: (01)04046964723995
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153293
• 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): 05/12/2022

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: 470185
• Device Catalogue Number: 470185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/12/2022
• 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