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)
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.Additional attempts to receive the sample are being made.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 or translucent floating particulate found during final inspection.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as event two of b.Braun medical inc.Internal report number (b)(4).Three (3) bags were received for evaluation.When the compounded solution was filtered, a blackish particle was found in one (1) of the bags.No particulate was found in the other two (2) returned bags.The particle was subjected to ft-ir analysis, and the analysis concluded that the particle was an elastomeric rubber material.This type of material is not used in any components of the bag.There were no product deviations, and the particles could not be attributed to the production process.Since the bags had been filled, it is possible that the contamination occurred during the filling process.Review of the device history record for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• 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: 9213822
• Report Number: 9681240-2019-00075
• Device Sequence Number: 19394344
• Product Code: KPE
• UDI-Device Identifier: 04046964539121
• UDI-Public: (01)04046964539121
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 11/25/2019

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: 10/22/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1