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

Catalog Number	352899
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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: customer reported that brown particles were found in the drip chamber.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was returned for further evaluation.Visual examination of the spike notes brown particles found in the drip chamber.No other visual defects observed.The sample and all information was forwarded to the supplier for further investigation.Per the supplier's investigation result, it was confirmed that the embedded foreign matter was degraded plastic (pvc) due to the high temperature during the molding process of the plasticization group.A batch review was conducted on the production records for the reported lot number and no anomalies were noted.The embedded spots in the pvc chambers is a cosmetic defect typical of the resin and does not affect the functionality or safety of the patient.In addition, a review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• 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: 7837115
• Report Number: 9614279-2018-00141
• Device Sequence Number: 2335990
• Product Code: FPA
• UDI-Device Identifier: 04046964181931
• UDI-Public: 04046964181931
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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: 04/30/2021
• Device Catalogue Number: 352899
• Device Lot Number: 0061621194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1