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

Model Number	2112532
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 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: small, hard, white sliver was found inside the final container.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) unused sample was received for evaluation.Upon visual inspection by the naked eye, one particle was detected.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 purchased 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 non-conformances.The supplier of the component was notified of this report.A project has been initiated to address issues involving this component.If additional pertinent information becomes available a follow-up report will be filed.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) unused sample was received for evaluation.Upon visual inspection by the naked eye, one particle was detected.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 purchased 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 non-conformances.The supplier of the component was notified of this report.A project has been initiated to address issues involving this component.If additional pertinent information becomes available a follow-up report will be filed.Corrected data: the method, results, and conclusion codes were updated to reflect the investigation results.

• 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: 9356078
• Report Number: 9681240-2019-00080
• Device Sequence Number: 1699355
• Product Code: KPE
• UDI-Device Identifier: 04046964539220
• UDI-Public: (01)04046964539220
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2019

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: 01/30/2022
• Device Model Number: 2112532
• Device Catalogue Number: 2112532
• Device Lot Number: 19B25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 10/26/2019
• Supplement Date Received by Manufacturer: 10/26/2019; 10/26/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/20/2019; 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1