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

Catalog Number	V7490
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 investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: set fell apart while priming blood.
Additional Manufacturer Narrative
(b)(4).One used outlook pump y-type blood set was received for evaluation.Upon visual examination a large amount of blood was observed throughout the set.The set was noted to be disconnected at the bonded joint between the distal end of the pump cassette and tubing.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances 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.Based on the results of this investigation, incidents of this nature are normally attributed to insufficient solvent applied, or the tubing not being fully inserted at the time of manual assembly.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: OUTLOOK®
• 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: 6267445
• Report Number: 9614279-2016-00273
• Device Sequence Number: 16374141
• Product Code: FPA
• UDI-Device Identifier: 04046964298738
• UDI-Public: (01)04046964298738(17)190718(10)0061519060
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K922637
• 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,Followup
• Report Date (Section B): 12/23/2016

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: 07/18/2019
• Device Catalogue Number: V7490
• Device Lot Number: 0061519060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1