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

Catalog Number	362006
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).No samples were returned in connection with this complaint.Without the actual device and/or lot number, a thorough investigation could not be performed.In addition, a review of the discrepancy management system database was unable to be performed because the lot number was reported as unknown.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.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
As reported by the user facility: event 1: customer reports, that there is an ongoing issue with the iv tubing.When the tubing is first opened, the connection at the stopcock is always loose to the point where the tubing comes apart during priming, unless you aggressively tighten it at the stopcock.The staff was educated to make sure it was tightened prior to priming to address the concern.In the last few weeks, multiple incidents occurred where the tubing separates after the iv was started, resulting in blood back flowing and leaking out of the tubing and all over the floor.This occurred even though the connection was tightened at the stopcock.No chemo involved as they are an endoscopy center general iv solution infusing.No injuries reported.

• 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: 7275735
• Report Number: 9614279-2018-00018
• Device Sequence Number: 18862632
• Product Code: FPA
• UDI-Device Identifier: 04046964293979
• UDI-Public: 04046964293979
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• 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): 02/15/2018

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 Catalogue Number: 362006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1