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 Codes	Break (1069); Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
The event occurred on (b)(6) and involved a 13" smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer, where it was reported that their nicu had experienced malfunctions in the last 3 weeks related to a broken filter.The stated issue was product disconnecting/falling apart.There was leaking and the defective product was infusing with fluid, total parenteral nutrition (tpn) and lipids.There were several patients involved, no patient harm but patients needed septic work ups, and there was delay in therapy as all tubing had to be changed delaying administration.This captures twelve of twenty occurrences.

• 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: 17421636
• Report Number: 9617594-2023-00458
• Device Sequence Number: 12548730
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: LIPIDS, UNK MFR; TOTAL PARENTERAL NUTRITION, UNK MFR; UNSPECIFIED FLUID, UNK MFR
• Patient Sex: Unknown