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

Catalog Number	354203
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 prior to priming the sets, a black foreign material was seen in the drip chamber.The drip chamber looks dirty overall, a couple of dark black spots were noted.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1)opened unused sample with packaging was returned for evaluation.The sample was visually inspected and several, large dark brown particulates were observed embedded in the clear plastic of the drip chamber.Visual inspection of the sample confirmed the reported mark on the drip chamber.The embedded material was confirmed to be degraded plastic due to the high temperature during the molding process of the plasticization group.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: 7661580
• Report Number: 9614279-2018-00097
• Device Sequence Number: 184572
• Product Code: FPA
• UDI-Device Identifier: 04046964182051
• UDI-Public: 04046964182051
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083723
• 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,Followup
• Report Date (Section B): 08/20/2018

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: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 354203
• Device Lot Number: 0061609488
• 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: 06/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1