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

Model Number	V7490
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: it was reported that the set was spiked and normal saline was primed through the tubing and the nurse noticed a white piece of plastic in the cassette.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400502724.One used sample in open packaging was provided for evaluation.A picture was also provided.The sample and photograph were both visually evaluated and the tube insert was present in the horizon cassette.The defect was present in both the sample and photograph submitted.Defect cause was due to the tube inserts being short.Since it was short, it was not held in the cassette and when the machine indexed, it rolled over onto another cassette.Generally, when this happens, they roll off onto the deck of the machine and the part gets rejected later in the process.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.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: OUTLOOK
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11344217
• Report Number: 2523676-2021-00049
• Device Sequence Number: 729510
• Product Code: FPA
• UDI-Device Identifier: 04046964189401
• UDI-Public: 04046964189401
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K922637
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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 Expiration Date: 07/31/2023
• Device Model Number: V7490
• Device Catalogue Number: V7490
• Device Lot Number: 0061744883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1