MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") PUR CLEAR/YELLOW BIFUSE ADD-ON SET W/CLAVE®, DRY SPIKE ADAPTER; STOPCOCK, I.V. SET

Catalog Number 011-H3362

Device Problem Fracture (1260)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

The incident involved is 41 cm (16") pur bifuse clear/yellow add-on set w/microclave®, dry spike adapter.The customer reported to the agence nationale de sécurité du médicament et des produits de santé (ansm, the national french regulatory agency) that when reconstituting the chemotherapy infusion, the tubing tip broke inside the chemo tree during inserting.Therefore, the activity was carried out with a loss of time and/or quality.The system was disassembled with return from the bag of chemotherapy at the oncopole for the preparation of a new bag and use of a second tubing set.It is unknown if the product is available for evaluation.The customer later reported to the manufacturer that there was no patient involvement because the incident occurred during chemotherapy preparation when connecting the tubing to the chemo tree.There were no adverse events and no human harm.There was a delay in therapy either a few minutes when the tip is removed from the chemo tree with kocher forceps or two hours late when the bag is sent back to the oncopole for preparation of a new one.The devices have been replaced and therapy completed.There was no need for additional medical intervention following the incidents.

Manufacturer Narrative

It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

• Brand Name: 41 CM (16") PUR CLEAR/YELLOW BIFUSE ADD-ON SET W/CLAVE®, DRY SPIKE ADAPTER
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16335591
• MDR Text Key: 309159497
• Report Number: 9617594-2023-00072
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619056681
• UDI-Public: (01)00840619056681(17)270501(10)5988044
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3362
• Device Lot Number: 5988044
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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
• Treatment: UNK CHEMOTHERAPY, UNK MFR