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

Model Number	513506
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
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: when pharmacy technician removed the protective cover, they noticed a black mark on the end of the tip.No injury reported.Per medwatch mw2200350000-2023-8009: pharmacy tech was processing an intravenous sterile compound product that required reconstitution with sterile water.The sterile water set-up requires a multi-ad fluid dispensing system.The pharmacy tech opened the sterile package containing the dispensing set, when they noticed a black blemish/mark on the tip of the transfer spike/needle.The pharmacy tech did not use this potential defective product.The product was quarantined and reported to the pharmacist.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One sample was received for evaluation.The returned sample was visually evaluated per specification, and it was noted the tip has a black mark on it.The reported defect was confirmed.Investigation by supplier determined that a burn area on the tip of the spike was present.The investigation found that this burning is caused by diesel effect due to partial occlusion of air exhaust of the mold.During their internal investigation, the supplier reviewed the maintenance of the mold, all records associated with finished goods, and no records of tip burned were recorded during their molding process.The supplier has found this to be an isolated event and the most probable root cause could be by improper segregation of the start-up of the molding machine.No corrective action was found to be needed at this time, and the issue was communicated to the molding area manager.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.

• Brand Name: MULTI-AD®
• Common Device Name: DISPENSER, LIQUID MEDICATI
• 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: 17239854
• Report Number: 2523676-2023-00312
• Device Sequence Number: 5260330
• Product Code: KYX
• UDI-Device Identifier: 04022495770394
• UDI-Public: (01)04022495770394
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K792227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: 513506
• Device Catalogue Number: 513506
• Device Lot Number: 0061865456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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