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

Catalog Number	490036
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).One (1) used sample without packaging was returned for evaluation.Upon visual evaluation, the distal backcheck valve, was noted to be disconnected at the sonic weld of the valve.The defect of the distal backcheck valve disconnecting at the sonic weld was confirmed through visual inspection.Review of the discrepancy management system (dsms) database was not possible as the lot number was reported as unknown.At this time a definitive root cause could not be determined; however, excessive handling could not be ruled out.We will maintain this report for further reference and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
As reported by the user facility: the set detached at the lowest y site at the backcheck valve which caused a small amount of blood to leak.There was no patient injury.

• 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: 7135619
• Report Number: 9614279-2017-00111
• Device Sequence Number: 11094830
• Product Code: FPA
• UDI-Device Identifier: 04046964185908
• UDI-Public: 4046964185908
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

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 Catalogue Number: 490036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1