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

Catalog Number	490452
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
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 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
As reported by the user facility: during therapy, it was reported that the primary set disconnection caused the patient to bleed out from the iv set.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual device was not returned for further evaluation; however, one (1) picture was provided by the facility for evaluation.The photo showed the set to be detached at the sonic weld of the backcheck valve.The photo confirmed the set to be detached at the sonic weld of the backcheck valve.Although the defect was confirmed, the exact root cause of the weakened/leaking sonic weld of the backcheck valve could not be determined at this time.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.
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 evaluation.Upon visual inspection, an unidentified luer connector was noted to be broke off in the port of the proximal caresite valve.Although the picture provided by the customer confirmed a bad sonic weld of the backcheck valve, upon visual inspection of the actual returned sample, an unidentified luer connector was noted to be broke off in the port of the proximal caresite valve.Leakage at the port of the carsite valve was confirmed to be due to a luer connector broken off in the port of the proximal caresite valve.While we are unable to determine the root cause of the reported defect, 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: ANESTHESIA IV SET
• 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: 7889719
• Report Number: 9614279-2018-00152
• Device Sequence Number: 2366015
• Product Code: FPA
• UDI-Device Identifier: 04046964848933
• UDI-Public: 04046964848933
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K153293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2018

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 Catalogue Number: 490452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 09/04/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/23/2018; 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1