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

Model Number	N7995
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
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 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: it was reported that ink was noted on the vial spike.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for evaluation.In addition one photo was also provided.Visual evaluation of the photo and sample confirmed dark embedded particulates in the addease spike.The particulates were identified as burnt/degraded resin.Visual examination of the sample and photo confirmed the reported defect.Incidents of embedded contamination are normally attributed to degraded/burned material or gases that may have become trapped in the vents at the time the part was molded.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.Although the defect was visually confirmed, there are no other complaints of this nature against this item or lot number, this is deemed an isolated incident.All available information regarding this occurrence has been forwarded to the appropriate manufacturing business unit to heighten awareness.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: ADDEASE
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 9720668
• Report Number: 2523676-2020-00022
• Device Sequence Number: 2352813
• Product Code: LHI
• UDI-Device Identifier: 04046964187018
• UDI-Public: 04046964187018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090905
• 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): 03/27/2020

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 Model Number: N7995
• Device Catalogue Number: N7995
• Device Lot Number: 0061696349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1