MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ADDEASE®; SET, I.V. FLUID TRANSFER

Catalog Number	N7995
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2024
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, our white addease connectors, n7995 have a short needle again and are unable to attach to 250ml bag properly.Upon reviewing the connectors in the bag lot 0061937209, we also noticed one of the connectors has white powder and seemed to be used.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two photographs and ninety- nine samples were provided for evaluation.Upon visual inspection of the returned photographs, one picture confirms a short cannula on one of the addease and the other picture confirms a white substance on the plastic spike of the addease.The ninety- nine returned samples were evaluated per specification.A total of forty- six out of the ninety- nine samples failed evaluation as the cannula was too short.A total of one out of the ninety- nine samples failed for foreign material on the plastic spike.Based on the data from the investigation, the reported defect was confirmed.A total of four retains from the reported lot number were reviewed per specification.It can be identified in all four retains that the spike is too short.An approved project is in place to further address issues with incorrect addease needle length.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: ADDEASE®
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109
• MDR Report Key: 20456679
• Report Number: 2523676-2024-00935
• Device Sequence Number: 20762868
• Product Code: LHI
• UDI-Device Identifier: 04046964187018
• UDI-Public: (01)04046964187018
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K090905
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: N7995
• Device Lot Number: 0061937209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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