MAUDE Adverse Event Report: 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)
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.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by the user facility: event 2: hair found in the port of the bag.
Additional Manufacturer Narrative
This report has been identified as event two of b.Braun medical inc.Internal report number (b)(4).Two (2) samples were received for evaluation.When the samples were visually inspected a hair was observed welded between the port and the bag in each of the two (2) samples.It was determined that this was the result of operator error during the manufacturing process, and an oversight during the final control phase.The production department has been informed in order to prevent future occurrences 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.
• MDR Report Key: 11824448
• Report Number: 9681240-2021-00002
• Device Sequence Number: 3909209
• Product Code: KPE
• UDI-Device Identifier: 04046964539206
• UDI-Public: (01)04046964539206
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/24/2021

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 Model Number: 2112531
• Device Catalogue Number: 2112531
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 08/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1