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

Catalog Number	474921
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The sample has been received and the investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.
Event or Problem Description
As reported by the user facility: the extension set was cracked at the hub which caused leakage of a scant amount of blood at the connection.No injuries reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used extension set in open packaging was returned in connection with this complaint.The returned sample was leakage tested, per specification, with passing results.Therefore, the reported defect was not confirmed.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: ULTRASITE®
• 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: 8117664
• Report Number: 9614279-2018-00204
• Device Sequence Number: 19207520
• Product Code: FPA
• UDI-Device Identifier: 04046964185748
• UDI-Public: 04046964185748
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K955585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: 07/31/2023
• Device Catalogue Number: 474921
• Device Lot Number: 0061633856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1