MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 257 CM (101") APPX 18.5 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, BACK CHECK VA; STOPCOCK, I.V. SET

Catalog Number 011-C6032

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

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is not yet received.

Event Description

The event occurred on an unspecified date and involved a 257 cm (101") appx 18.5 ml, 20 drop blood set w/200 micron filter, back check valve, 2 clave¿ clear, spin luer.The customer stated that the iv tubing disconnected from the filter chamber in the middle of patient use.The solution used was a compound sodium lactate.The set was replaced, rimed another set and continued surgery.There was no specific damage noted on the set like crack or breakage.There was patient involvement, no patient harm, no delay in therapy and no one was harmed as a result of the reported event.This report is two of two.

Manufacturer Narrative

The device was received for evaluation on 12/11/2023 and connected to unknown extension set.As received it was confirmed a tube separation from the drip chamber on both samples.The tube was observed through uv light and was confirmed insufficient presence of solvent, no additional damage or anomalies were confirmed.The outside diameter of the tube was measured and confirmed to be within specification.Complaint of separation can be confirmed.The probable cause is due to insufficient solvent applied during manual process assembly at manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 257 CM (101") APPX 18.5 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, BACK CHECK VA
• 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: 18266483
• MDR Text Key: 329726323
• Report Number: 9617594-2023-01068
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619004729
• UDI-Public: (01)00840619004729(17)260501(10)5376679
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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: 011-C6032
• Device Lot Number: 5376679
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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: COMPOUND SODIUM LACTATE, MFR UNK.