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

Catalog Number	471960
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The sample has not yet 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 female luer which caused leakage.Pack red blood cells (prbc) were infusing when the leak was observed.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 and one (1) photo were returned for evaluation.The used sample was returned attached to a straight caresite valve.Visual examination of the returned set and photo confirmed a vertical crack in the female connector.Therefore, the reported defect was confirmed.A review of the discrepancy management system (dsms) database was unable to be performed as the lot number was reported as unknown.Although the defect of leakage was confirmed, the exact root cause of the crack on the female connector was not able to be determined at this time.We will maintain this report for future reference and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: EXTENSION 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: 8166563
• Report Number: 9614279-2018-00213
• Device Sequence Number: 2024792
• Product Code: FPA
• UDI-Device Identifier: 04022495770127
• UDI-Public: 04022495770127
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• 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): 01/29/2019

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: 471960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1