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

Catalog Number	470172
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as event four b.Braun inc.Internal report # (b)(4).Four (4) used contaminated samples were returned for evaluation of this complaint.The used samples were visually examined under magnification and there was a crack seen on the threads of one of the four care site valves.Two of the samples appeared to have the male connector broken off in the care site.Could not decontaminate any of the samples to the point where physical testing could take place.Customer's complaint is justified.Although a definitive conclusion could not be made regarding the cause of the reported event, cracking of this nature can occur when the product is subjected to aggressive solvents/drugs, excessive mechanical stresses (over-tightening), or other various unforeseen circumstances during the clinical application.Note: this case is being filed retrospectively as a result of a review of recent customer complaint information.Based on additional information and details provided in another complaint case, it was determined that this case is reportable in accordance with the requirements of 21 cfr 803.B.Braun has conducted a retrospective review for all complaints of a similar nature in accordance with internal procedure (b)(4).
Event or Problem Description
As reported by user facility: event 4.Reports witnessed patient in dialysis receiving infusion/transfusion blood was leaking out of the port site sides it appeared.Noted to have happened approximately 5 times.No patient injury.

• 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, dominican republic ; DR
• MDR Report Key: 6118333
• Report Number: 9614279-2016-00172
• Device Sequence Number: 13465974
• Product Code: FPA
• UDI-Device Identifier: 04046964580215
• UDI-Public: (01)04046964580215(17)181231(10)0061469780
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2016

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: 12/31/2018
• Device Catalogue Number: 470172
• Device Lot Number: 0061469780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2016
• Initial Report FDA Received Date: 11/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1