MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MULTI-AD®; DISPENSER, LIQUID MEDICATI

Catalog Number 513548

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

As reported by the user facility: customer states brown contamination on spike port.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample was submitted to the manufacturer for evaluation.Through visual examination, a brown grease like substance on the spike tip was observed.The sample is not within specification and the reported defect is confirmed.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.The defect is a result of a failure in the production process at a supplier site; it was determined that the grease was coming from the molding machine.An approved project is in place to further address issues with foreign matter fluid path.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: MULTI-AD®
• Type of Device: DISPENSER, LIQUID MEDICATI
• 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: 18253618
• MDR Text Key: 329566930
• Report Number: 2523676-2023-00775
• Device Sequence Number: 1
• Product Code: KYX
• UDI-Device Identifier: 04022495818348
• UDI-Public: (01)04022495818348
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K792227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 513548
• Device Lot Number: 0061845001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1