MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F; STOPCOCK, I.V. SET

Catalog Number	B33902
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 13" smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer from which the filter had been pulled apart.The customer stated that, when a filter disconnects, the line and filter lay in an open bed for just a few minutes.A few minutes is all is needed to introduce a life-threatening infection to a premature or term neonate because their immune systems are very underdeveloped.When this happens, this facility's nurses completely stop the fluids and also change out the lines.Each of the patients has to receive a full sepsis lab work-up and if the patient starts showing sign of illness, then antibiotics would need to be started.The customer stated that this can be very dangerous for the patient and also concerning for families/others involved in the patient's care.There was no report of specific actual human harm to any patient in this complaint.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
One used partial.List (b)(6), 13" smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer; lot #13605717 was returned for investigation.The filter and distal tubing were the only parts of the device received, and the separated tube was not provided.Two photos were also provided for evaluation.No additional damage or abnormally were observed.No mating device was returned.There was no solvent observed in the filter.The complaint of separation can be confirmed based on the returned filter and the photos provided by the customer.The probable cause was due to insufficient solvent applied in the tube during the manual assembly process in manufacturing.

• Brand Name: 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F
• 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: 17396976
• Report Number: 9617594-2023-00436
• Device Sequence Number: 5922335
• Product Code: FMG
• UDI-Device Identifier: 00887709071681
• UDI-Public: (01)00887709071681(17)280401(10)13605717
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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 Catalogue Number: B33902
• Device Lot Number: 13605717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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: UNSPEC. TOTAL PARENTERAL NUTRITION (TPN), MFR UNK.; UNSPECIFIED LIPIDS, MFR UNK.
• Patient Sex: Unknown