MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 15.4 ML, 10 DROP ADMIN SET W/0.2 MICRON FILTER, CLAVE®, ROTAT; STOPCOCK, I.V. SET

Catalog Number B9650

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unspecified date and involved a 102" (259 cm) appx 15.4 ml, 10 drop admin set w/0.2 micron filter, clave®, rotating luer where it was reported one of the intravenous (iv) admin sets had a cracked inlet and was releasing blood onto the patient's arm.There was patient involvement and no adverse event reported.

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.Additional contact: (b)(6).

• Brand Name: 102" (259 CM) APPX 15.4 ML, 10 DROP ADMIN SET W/0.2 MICRON FILTER, CLAVE®, ROTAT
• 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: 17917169
• MDR Text Key: 326257945
• Report Number: 9617594-2023-00822
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709014763
• UDI-Public: (01)00887709014763(17)270801(10)8359976
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: B9650
• Device Lot Number: 8359976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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