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

Catalog Number	354205
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
(b)(4).Event description: i was priming iv tubing and the tubing fell apart at a port connection.The tubing was not connected to a patient.1 week ago i remember the same type tubing falling apart on a patient, blood started backing up and running on the floor.I disconnected tubing and threw it away.No harm to that patient.At the time i thought possibly the tubing was damaged during transporting the patient, but now looking back i believe the tubing must have been faulty as well.No one saw the tubing get damaged.There is one event being reported for blood leakage.No patient injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample with no packaging was returned for evaluation.Upon visual examination, the set was noted to be disconnected at the bonded joint between the tubing and sidearm of the distal caresite.The reported defect was confirmed.Although the reported defect was confirmed the exact root cause could not be determined.B.Braun medical inc.Has initiated a corrective action and preventative action (capa) to address issues of disconnection at the bonded joint between the tubing and y-carestie valve.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample.Without the actual device, a thorough investigation could not be performed.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformance of this nature.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: 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: 6927869
• Report Number: 9614279-2017-00091
• Device Sequence Number: 1409072
• Product Code: FPA
• UDI-Device Identifier: 04046964182099
• UDI-Public: 04046964182099
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2017

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: 04/30/2020
• Device Catalogue Number: 354205
• Device Lot Number: 0061566519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 09/18/2017; 09/18/2017
• Initial Report FDA Received Date: 10/08/2017
• Supplement Report FDA Received Date: 10/19/2017; 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR