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

Catalog Number	354210
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).One used sample, without packaging was returned for evaluation.Upon visual inspection, it was noted that the tubing at the distal caresite y-site arm port was disconnected.Pictures were taken upon incoming.Upon further observation, it was noted that very little solvent residue between the connection tubing and the y-site arm port was present.The customer's complaint is justified.The root cause of this occurrence could not be definitively determined at this time.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the assembler may attribute to an incident of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.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: reports when patient came out of surgery there was blood everywhere in the bed.Blood had backed up the line and was leaking out from above the lower y-site.It was uncertain of the length of time that the set had come apart.Set separated above the distal y-site connector.Everything below the y-site is intact.No patient injury.

• Brand Name: IV ADMINISTRATION 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: 6124411
• Report Number: 9614279-2016-00109
• Device Sequence Number: 998540
• Product Code: FPA
• UDI-Device Identifier: 04046964182174
• UDI-Public: (01)04046964182174(17)190131(10)0061482996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2016

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: 01/31/2019
• Device Catalogue Number: 354210
• Device Lot Number: 0061482996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• 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