MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. INFUSOMAT®; SET, ADMINISTRATION, INTRA

Catalog Number	363232
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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: during chemotherapy - unknown agent leaked at y-site.No injuries reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used without packaging and one un -opened sample were returned for evaluation.The samples were visually inspected and no manufacturing defects were noted.Both sets were tested for leakage per specification with passing results.No leakage was observed from any location of either set.In addition, all ultrasite valves were accessed with a syringe and the sets were tested a second time, again with passing results.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.While we are unable to confirm the reported defect, we will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• MDR Report Key: 6671912
• Report Number: 9614279-2017-00058
• Device Sequence Number: 19111477
• Product Code: FPA
• UDI-Device Identifier: 04046964294532
• UDI-Public: 04046964294532
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K031923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2017

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: 01/31/2022
• Device Catalogue Number: 363232
• Device Lot Number: 0061549436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1