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

Model Number	470116
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: air in line during use.Air was introduced into the patient causing elevated t-wave required stay overnight and observation.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) samples with packaging were returned for evaluation.Both samples were tested for occlusion and leakage per specification.In addition in order to replicate the incident, the sets were spiked and primed with normal saline solution per the ifu.No bubbles or any air in the lines was observed.The reported defect was confirmed.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformance of this nature.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.

• 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: 6420237
• Report Number: 9614279-2017-00029
• Device Sequence Number: 19061556
• Product Code: FPA
• UDI-Device Identifier: 04046964183973
• UDI-Public: (01)04046964183973(17)190917(10)0061530658
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2019
• Device Model Number: 470116
• Device Catalogue Number: 470116
• Device Lot Number: 0061530658
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/09/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 1 YR