MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 122" 15 DROP PRIMARY SET W/REMV 3 GANG 4-WAY STOPCOCKS, CLAVE¿, ROTATING LUER, 2; STOPCOCK, I.V. SET

Catalog Number B9784

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that, on an unknown date, a 122" 15 drop primary set w/remv 3 gang 4-way stopcocks, clave®, rotating luer, 2 ext with list number b9784 and provided lot number 1373058.The report states that they had a complaint about the distal-end priming cap being changed to a less user-friendly dead-end cap that would not stay connected once removed to prime the line.The new cap was visibly and functionally different than what they were accustomed to.The new caps were constantly falling off when being moved/transported because they did not fit snugly onto the male luer once they had been removed to prime the line.There was no patient harm reported.

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.

• Brand Name: 122" 15 DROP PRIMARY SET W/REMV 3 GANG 4-WAY STOPCOCKS, CLAVE¿, ROTATING LUER, 2
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18282472
• MDR Text Key: 330026257
• Report Number: 9617594-2023-01098
• Device Sequence Number: 1
• Product Code: FMG
• 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: Physician
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B9784
• Device Lot Number: 13730508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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