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

Model Number	363032
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
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: it was reported that foreign matter was found in buretrol while priming set-up for lipids.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A photo was provided for further evaluation.Visual examination noted threads present inside the burette.The photo and all available information were forwarded to the manufacturer for further evaluation.Based on the evaluation results, the manufacturer stated that this issue could have occurred during the assembly of the product.The reported defect was confirmed.The production records were reviewed by the supplier and no abnormalities were found.The supplier stated that this is an isolated incident; however, all production personnel have been advised of this event underlining the importance of correctly applying the dressing during the dressing procedure.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: INFUSOMAT
• 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: 9569567
• Report Number: 9614279-2019-00237
• Device Sequence Number: 438727
• Product Code: FPA
• UDI-Device Identifier: 04046964294297
• UDI-Public: 04046964294297
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 10/31/2022
• Device Model Number: 363032
• Device Catalogue Number: 363032
• Device Lot Number: 0061650665
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1