MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CHEMO DISPENSING PIN¿; LHI-SET, I.V. FLUID TRANSFER

Catalog Number	412014
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by a b.Braun global affiliate: i would like to raise the attached supplier corrective action.We have been observing presence of particulate matter in our finished product, hence we investigated our particulates and one of those was cellulose.One of the sources we suspect cellulose to have emerged is chemo dispensing pins manufactured by b.Braun, as this contains a paper filter with which our product comes in contact with.Also, can cellulose emerge from chemo dispensing pin paper packaging?.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Five (5) unused sample in open package were returned for evaluation.The received samples were visually evaluated and did not show any evidence of particulate.The reported defect 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: CHEMO DISPENSING PIN¿
• Common Device Name: LHI-SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 19608658
• Report Number: 2523676-2024-00638
• Device Sequence Number: 8121072
• Product Code: LHI
• UDI-Device Identifier: 04022495095893
• UDI-Public: (01)04022495095893
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K925401
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 412014
• Device Lot Number: 0061864170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2022
• 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