MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE),; STOPCOCK, I.V. SET

Model Number	MC330428
Medical Device Problem Codes	Disconnection (1171); Mechanical Problem (1384)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.
Event or Problem Description
A user facility mandatory medwatch report # 4633010000-2022-8019 was received that stated: "health care provider was switching the norepinephrine syringe per protocol using the two syringe method and extension tubing.After having the second syringe running for 15 mins to make sure it was engaged, health care provider went to disconnect the tubing from the first extension on the norepinephrine tubing and as health care provider pulled on the clave and tubing, the tubing disconnected from the clave.Health care provider then had to re prime new tubing for the norepinephrine syringe.Patient was running at 0.07mcg/kg/hr.And his blood pressure dropped from mean arterial pressure (maps) of 75 to maps of 55.Health care provider was able to quickly reconnect and get it running again but it took about 6-8 mins to see a bump in patient's blood pressure again.While this was not immediately life threatening for this specific patient if he was more sensitive to changes in this medications it could have required much more intervention and possibly coding the patient".The event occured in the picu and involved a 71" (180 cm) appx 0.44 ml, smallbore ext set w/microclave® clear, clamp (blue), rotating luer.There was patient involvement, however, there was no harm reported.

• Brand Name: 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE),
• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15519843
• Report Number: 9617594-2022-00283
• Device Sequence Number: 5990784
• Product Code: FMG
• UDI-Device Identifier: 00887709088344
• UDI-Public: (01)00887709088344(17)270601(10)5997951
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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 Model Number: MC330428
• Device Catalogue Number: MC330428
• Device Lot Number: 5997951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOREPINEPHRINE SYRINGE, MFR UNK
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 40 KG