MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" EXT SET, 3 GANG 1O2 MANIFOLD W/BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	B55013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
Event or Problem Description
The event involved a 12" ext set, 3 gang 1o2® manifold w/baseplate, rotating luer where the bridge for sedation/paralytic was found to be leaking.Subtle leaks were reported to be difficult to see however, it was suspected that the leakage was coming from where the plastic meets the port.The leak occurred within 12 hours of using as a new admission.The problem was noticed when the patient started moving his head.It was reported that the patient was on propofol at 4mg/kg/hr, dilaudid at 3mg/hr and cisatracurium at 10mg/hr.The reporter mentioned that the patient typically de-saturates dramatically when paralytic is off, but fortunately it did not happen this time.After the patient became agitated, the bridge was changed out and boluses were given for quick re-sedation.There was patient involvement and no human harm.

• Brand Name: 12" EXT SET, 3 GANG 1O2 MANIFOLD W/BASEPLATE, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 11625056
• Report Number: 9617594-2021-00114
• Device Sequence Number: 14268559
• Product Code: FMG
• UDI-Device Identifier: 00887709010116
• UDI-Public: (01)00887709010116(17)251001(10)5047809
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: 10/01/2025
• Device Model Number: B55013
• Device Catalogue Number: B55013
• Device Lot Number: 5047809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1