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

Catalog Number	2112529
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2013017 b.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun italy s.P.A.(manufacturer).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.Found a white floater in the final container.No patient involvement.
Additional Manufacturer Narrative
Exemption number e2013017.(b)(4).This report has been identified as event two of b.Braun medical inc.Internal report number (b)(4).One sample was received for evaluation.The solution in the bag was filtered out, and after filtration a white particle of about.2mm was present on the filtration membrane.There was not enough of the particulate on the membrane to send it for ft-ir analysis, and therefore the substance could not be identified.There is not a point within the production process where a particulate matching the one found would be present.As a result, we have determined that the particulate did not originate from the production process.A batch record review for the reported lot number did not reveal any abnormalities or non-conformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.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; mirandola 41037 ; IT 41037
• MDR Report Key: 8071209
• Report Number: 9681240-2018-00025
• Device Sequence Number: 1928989
• 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): 01/23/2019
• Report Date (Section F): 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2020
• Device Catalogue Number: 2112529
• Device Lot Number: 17M04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/05/2018
• Device Age: 11 MO
• Event Location: Other
• Date Report to Manufacturer: 01/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/23/2019