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

Catalog Number	470106-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple unsuccessful attempts were made to obtain a sample and additional information.No additional information was received; because of this, further investigation of the complaint is not possible and no conclusion could be drawn.Although no sample was returned due to this complaint and other confirmed complaints of this nature, b.Braun medical initiated a corrective action/ preventative action to address the issue of the cracks in the caresite luer which provides for root cause investigation and corrective action.We will maintain this report for further references and continue to monitor other reports for similar occurrences.
Event or Problem Description
As reported by the user facility: while flusing the y-extension set, it broke causing the set to leak blood.

• Brand Name: CARESITE®
• 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: 6610501
• Report Number: 9614279-2017-00048
• Device Sequence Number: 495502
• Product Code: FPA
• UDI-Device Identifier: 04046964093739
• UDI-Public: (01)04046964093739(17)190214(10)0061489341
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2017

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: 02/14/2019
• Device Catalogue Number: 470106-01
• Device Lot Number: 0061489341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1