MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") APPX 3.1 ML, SET PER INFUSIONE, 4 CLAVE® CONNECTOR, FILTRO; STOPCOCK, I.V. SET

Catalog Number 011-H1268

Device Problem Material Separation (1562)

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

Event Date 09/29/2023

Event Type  malfunction  

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.

Event Description

Lt was reported that a 30 cm (12") appx 3.2 ml, set per infusione, 4 clave® connector, filtro disconnected when connecting chemotherapy on the tree.The blue valve has been unscrewed and disconnected.Actions taken: changing the defective 4-way tree.The nurse reported the event to the pharmacy.The status of the product at the time of the event was when connecting the chemotherapy to the tree.There was no patient harm reported.

Manufacturer Narrative

It was observed and confirmed that one of the clave connectors bonded to the trifurcated adapter of the 011-h1268 set had become separated at the bond.The clave port of the bond was not returned.The bond was analyzed using uv light and it was found that there was insufficient solvent applied at the bond interface which led to the unintended separation during use.The probable cause is typical of insufficient solvent coverage during manual bonding in ensenada.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 1/30/2024.

• Brand Name: 30 CM (12") APPX 3.1 ML, SET PER INFUSIONE, 4 CLAVE® CONNECTOR, FILTRO
• 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: 18390069
• MDR Text Key: 331379602
• Report Number: 9617594-2023-01193
• 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: Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1268
• Device Lot Number: 10996799
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• 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