MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MINI-SPIKE; SET, I.V. FLUID TRANSFER

Model Number	412004
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 internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: a red fiber was observed within the final product bag.Due to the nature of the manufacturing process, one of many materials/consumables used could have introduced this particulate.[customer is] reaching out to several suppliers.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No samples were returned for evaluation.Several photos were provided.Upon visual inspection, a red fiber-like foreign material was identified within the packaging.Based on the photos, no specific conclusions can be made regarding the source of the material.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.In response to this occurrence, a formal awareness training session was conducted with all applicable personnel involved in the assembly and inspection of this product.The purpose of this training was to review the reported incident and to ensure all personnel understand and comply with the established assembly and inspection processes.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: MINI-SPIKE
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown,
• MDR Report Key: 10179988
• Report Number: 2523676-2020-00181
• Device Sequence Number: 2654017
• Product Code: LHI
• UDI-Device Identifier: 04046963497484
• UDI-Public: 04046963497484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K925401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: 05/31/2024
• Device Model Number: 412004
• Device Catalogue Number: 412004
• Device Lot Number: 0061676412
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1