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)
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 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: found a very small white floater in a 500ml neonatal bag.No patient involvement.
Additional Manufacturer Narrative
Exemption number e2013017.(b)(4).This report has been identified as b.Braun medical inc.Internal report number (b)(4).One filled bag was received for evaluation.Upon visual inspection by the naked eye, it was not possible to detect any foreign material.However, when the solution was filtered a 1 mm long white particle was found.This particle was identified as acrylonitrile butadiene styrene (abs) under ft-ir analysis.There is a component of the bag assembly that is made from abs.As a result, the component of the bag made from abs could not be excluded as the source of the contamination.The component containing abs is purchsed from an approved supplier and goes through an incoming inspection before being used in production.A device history record review was performed for the component going back two years, and this review did not reveal any abnormalities or nonconformances.The supplier of the component was notified of this report.Additionally, five (5) unused bags were also returned for evaluation.The bags were visually inspected and no foreign material was detected.The bags were then filled with sterile solution and this solution was then filtered to verify if any particulate was present.After filtration the filter membrane was microscopically inspected and no particulate was detected.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.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; mirandola 41037 ; IT 41037
• MDR Report Key: 8046003
• Report Number: 9681240-2018-00022
• Device Sequence Number: 1472764
• 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: 06/30/2019
• Device Catalogue Number: 2112529
• Device Lot Number: 16G21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/26/2018
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 01/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/07/2018
• 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