MAUDE Adverse Event Report: B. BRAUN AVITUM ITALY S.P.A. APEX¿; CONTAINER, I.V.

Model Number	2112529
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event two of b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: event 2: small white particulate floating in the bag after compounding.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as event two of b.Braun medical inc.Internal report number (b)(4).One (1) sample was received for evaluation.The bag was visually inspected and no evidence of any particles were found in the bag.Afterwards, the sample was delivered to the biological laboratory for filtration on a black membrane, and no particles were found.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.If additional information becomes available, a follow up report will be submitted.

• Brand Name: APEX¿
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): B. BRAUN AVITUM ITALY S.P.A.; via xxv luglio 11; 41037 ; IT 41037
• MDR Report Key: 9157058
• Report Number: 9681240-2019-00073
• Device Sequence Number: 16625445
• Product Code: KPE
• UDI-Device Identifier: 04046964539121
• UDI-Public: (01)04046964539121
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 12/30/2021
• Device Model Number: 2112529
• Device Catalogue Number: 2112529
• Device Lot Number: 19A23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1