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

Catalog Number	363220
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
(b)(4).Three used samples were returned for evaluation.Upon visual inspection, one of the samples had the bottom of the distal backcheck valve broken off into the sidearm of the distal ultrasite valve.This appeared to be the result of excess force applied at some time during the handling/use of the set.The other two samples were tested for leakage per the specification and leakage was observed at the bonded joint between the proximal backcheck valve and the ultrasite valve on one of the sets.There was no leakage detected on the other set.This returned set met requirements according to specification, and the reported failure could not be reproduced.During the complaint review process for the reported catalog number and lot number a trend was identified and capa (b)(4) was opened to address leaking at the bonded joint.The product dimensions were modified and a new assembly fixture was implemented to allow for better bonding.The assembly procedure was updated, and the appropriate personnel were trained on the updated procedure.This capa is now closed.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.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 2: leaking at blood filter.

• Brand Name: INFUSOMAT®
• 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: 6124500
• Report Number: 9614279-2016-00100
• Device Sequence Number: 18927034
• Product Code: FPA
• UDI-Device Identifier: 04046964294396
• UDI-Public: (01)04046964294396(17)191130(10)0061404430
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142036
• 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): 02/10/2015

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: 11/30/2019
• Device Catalogue Number: 363220
• Device Lot Number: 0061404430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2015
• Initial Report FDA Received Date: 11/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1