MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC THREE GANG LARGE BORE STOPCOCK MANIFOLD; STOPCOCK, I.V. SET

Catalog Number	2C6218
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Exsanguination (1841)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient experienced significant blood loss leading to a near fatal arrest after a separation/ disconnection of a three gang large bore stopcock manifold occurred while in use.The device became separated/ disconnected at "the points where the stopcocks are fused".The device was in use with an unreported medication.The cause of the separation was not reported.It was reported after the separation occurred, the patient subsequently exsanguinated and ¿arrested¿ (no further details).Treatment and interventions for the events were not reported.At the time of this report the patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: THREE GANG LARGE BORE STOPCOCK MANIFOLD
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• MDR Report Key: 7970790
• Report Number: 1416980-2018-06581
• Device Sequence Number: 1682118
• Product Code: FMG
• UDI-Device Identifier: 00085412003863
• UDI-Public: (01)00085412003863
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2023
• Device Catalogue Number: 2C6218
• Device Lot Number: DR18E02047
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other