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

Catalog Number	354220
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
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 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: it was reported that a foreign object was found in the iv line of a patient.Unsure if the foreign object actually came from the iv line or not.A 1000mls of normal saline was being infused.No injury reported.
Additional Manufacturer Narrative
(b)(4).One (1) used sample with no packaging was returned for evaluation.In order to not interfere with the investigation, the sample was not decontaminated.The extension was examined and there was clear residual fluid and blood residue observed.No particulate or foreign matter was observed.The extension set was examined a second time under magnification and still no particulate or foreign matter was able to be seen.The returned sample was visually inspected and examined and the reported defect was unable to be confirmed.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non- conformances noted during in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• 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: 7626738
• Report Number: 9614279-2018-00094
• Device Sequence Number: 1946610
• Product Code: FPA
• UDI-Device Identifier: 04046964182358
• UDI-Public: 04046964182358
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• 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): 07/12/2018

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: 02/28/2021
• Device Catalogue Number: 354220
• Device Lot Number: 0061612770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1