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

Catalog Number	NF1290
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (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: customer reports, that a white piece appears to be lodged inside the iv tubing right above the lower y port.The nurse tested a set to see if the set is blocked and she reported that the iv administration set is not occluded.No injuries.The set was not used on a patient.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned to evaluate, however the picture provided was analyzed and the white piece is a flow restrictor designed to be there per manufacturing requirements.Although the picture provided does show a white piece, this iv set is design to have a flow restrictor.Therefore this complaint cannot be confirmed.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Based on the results of the picture evaluation, the product met internal specifications.The iv set is designed to have a flow restrictor.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.

• Brand Name: SAFELINE®
• 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: 7332322
• Report Number: 9614279-2018-00053
• Device Sequence Number: 1629893
• Product Code: FPA
• UDI-Device Identifier: 04046964187148
• UDI-Public: 04046964187148
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K931377
• 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): 04/20/2018

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: No Information
• Device Expiration Date: 10/18/2021
• Device Catalogue Number: NF1290
• Device Lot Number: 0061535594
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1