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

Model Number	470065
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
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 patient: "the failure i experienced a few days ago was between the light green female luer on the 17" extension set and the backcheck flow valve.They disconnected entirely while infusing (an extremely slow rate of 12.5ml/hr) which resulted in blood coming out the extension set." no injury reported.Possible lot numbers provided: lot number 0061757951: expiry date 12/31/2025; production date 01/07/2021.Lot number 0061735484: expiry date 04/30/2025; production date 05/22/2020.Lot number 0061749271: expiry date 08/31/2025; production date 09/11/2020.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Visual evaluation on the photograph displays two circled locations on the set where the reported leakage was identified.The second photograph displays an open extension, no conclusions were able to be made based on the photographs.No root cause could be determined at this time.Retained units were evaluated and passed the internal testing.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.In addition, 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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Four (4) samples without packaging were provided for evaluation.Photos were also provided.The first photo displayed two circled locations on the set where leakage was reported.The second photo displays an open extension no defects were observed, no conclusions were able to be made based on the photographs.The samples were visually evaluated and no defects were observed.Additionally, the sets were functionally tested with passing results.Based on the evaluation results, the reported defect of leakage was 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: EXTENSION SET
• 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: 11786967
• Report Number: 2523676-2021-00108
• Device Sequence Number: 3869141
• Product Code: FPA
• UDI-Device Identifier: 04046964298097
• UDI-Public: 04046964298097
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2022

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: Lay User/Patient
• Device Model Number: 470065
• Device Catalogue Number: 470065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021; 04/22/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/27/2021; 01/31/2022
• 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