MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 32 CM (13") APPX 3.3 ML, SET AMBRATO PER INFUSIONE PER POMPA CON PERFORATORE CON; STOPCOCK, I.V. SET

Catalog Number 011-H2799

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

A used 011-h2799 assembly was returned on 1-nov-2023 and confirmed with one of the four ports separated at the bond to the trifuse adapter.Visual examination under uv light revealed inadequate solvent coverage at the bond that separated.Subsequent functional testing showed that several of the intact bonds did not meet bond integrity testing.The probable cause of the bond separations is typical of inadequate solvent applied during manual bond assembly in ensenada.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

Event Description

The incident involved a 32 cm (13") appx 3.3 ml, set ambrato per infusione per pompa con perforatore con valvola e 4 accessi con bcv.The customer stated that there was a detachment of one of the check valves from the main tree during the rinsing of the line.This report captures an additional used sample that was received for testing from the customer.There was unknown patient involvement but no report of harm.

• Brand Name: 32 CM (13") APPX 3.3 ML, SET AMBRATO PER INFUSIONE PER POMPA CON PERFORATORE CON
• 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: 18268273
• MDR Text Key: 329741486
• Report Number: 9617594-2023-01071
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H2799
• Device Lot Number: 13522551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2023
• 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