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

Device Problems Break (1069); Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2023

Event Type  malfunction  

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 Description

The event occurred on from late (b)(6) through mid (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 eleven of twenty occurrences.

• Brand Name: 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F
• Type of Device: 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: 17421629
• MDR Text Key: 320689532
• Report Number: 9617594-2023-00457
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709071681
• UDI-Public: (01)00887709071681(17)280401(10)13605717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B33902
• Device Lot Number: 13605717
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LIPIDS, UNK MFR; TOTAL PARENTERAL NUTRITION, UNK MFR; UNSPECIFIED FLUID, UNK MFR