MAUDE Adverse Event Report: B. BRAUN DOMINICIAN REPULIC INC. SAFEDAY; SET, ADMINISTRATION, INTRA

Model Number	352900
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2019
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: per end user, the y-site has black "ink type" substance on it.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused segment of tubing containing the drip chamber and spike was returned for evaluation.In addition a photograph of the defect was also provided.Visual examination of the sample noted black material on the spike.Based on the evaluation of the sample the reported defect is confirmed.The universal vented spike is a purchased part.The provided photo, sample, and all related information were forwarded to the supplier for further evaluation.Based on the manufacture's evaluation, an analysis was done on the area of the embedded spot on the spike.The result of the analysis confirmed that the embedded spots are abs material, the same one used to mold the spike.A possible root cause can be a grain of resin with degradation embedded or an incorrect segregation during the production startup of the spike.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: SAFEDAY
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; DR
• MDR Report Key: 9595930
• Report Number: 9614279-2019-00241
• Device Sequence Number: 14078356
• Product Code: FPA
• UDI-Device Identifier: 04046964181955
• UDI-Public: 04046964181955
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• 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
• Report Date (Section B): 03/23/2020

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: 09/30/2022
• Device Model Number: 352900
• Device Catalogue Number: 352900
• Device Lot Number: 0061700249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1