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

Model Number	2112531
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as 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: hair discovered in injection port of 2l single chamber final container.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).A photo was provided for evaluation.In the photo a hair can be seen.In order to have the hair in the location observed in the photo, the contamination would have occurred during the assembly of the bag.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.House retain samples from the reported batch were also evaluated and no abnormalities or non-conformances of this nature were observed.As a result, this incident has been determined to be an isolated incident.The applicable manufacturing personnel have been informed.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; mirandola 41037 ; IT 41037
• MDR Report Key: 10507087
• Report Number: 9681240-2020-00004
• Device Sequence Number: 3344414
• Product Code: KPE
• UDI-Device Identifier: 04046964539206
• UDI-Public: (01)04046964539206
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041415
• 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): 10/26/2020

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: 01/30/2023
• Device Model Number: 2112531
• Device Catalogue Number: 2112531
• Device Lot Number: 20B26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1