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

Catalog Number	352894
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).The sample has not yet been received and the investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.
Event or Problem Description
As reported by the user facility: the iv set leaked chemotherapy at the upper y-site junction.No injuries reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) used samples without packaging were returned for evaluation.The returned sets were tested for leakage per specification with failing results.One set was found to be leaking from the sonic weld of the proximal safeday ultrasite valve.The second set was found to be leaking at the bonded joint between the bottom of the backcheck valve and sidearm of the proximal ultrasite valve.The reported defect of leakage was confirmed through physical testing.As a result of this incident and other confirmed complaints, the parameters for the sonic weld machine were adjusted to create stronger sonic welds.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: SAFEDAY¿
• 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: 7523400
• Report Number: 9614279-2018-00084
• Device Sequence Number: 13839184
• Product Code: FPA
• UDI-Device Identifier: 04046964181894
• UDI-Public: 04046964181894
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 11/30/2020
• Device Catalogue Number: 352894
• Device Lot Number: 0061595764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1