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

Catalog Number 011-H3362-10

Device Problems Fracture (1260); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/16/2022

Event Type  malfunction  

Event Description

The event involved a 41 cm (16") pur bifuse clear/yellow add-on set w/microclave®, dry spike adapter, 10 units.The customer reported that the tubing tip broke inside the chemo tree during insertion.The broken tip was removed from the tubing with pliers kocher.The system was required to be completely dismantled, the bag was returned to the to the hospital pharmacy and a new bag was required to be prepared).Therapy was completed with a second tubing set.The customer provided additional information subsequent to logging the initial complaint indicating that the event occurred during use on a patient but there were no clinical consequences.There was no injury or contamination (exposure) for the patient or caregivers and no additional medical intervention was required following the incident.There were various medications in use at the time of the event.There was no blood loss of clinical significance.

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: 41 CM (16") PUR BIFUSE CLEAR/YELLOW ADD-ON SET W/MICROCLAVE®, 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: 16307123
• MDR Text Key: 309160465
• Report Number: 9617594-2023-00061
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619094980
• UDI-Public: (01)00840619094980(17)270501(10)5989721
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3362-10
• Device Lot Number: 5989721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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: IV BAG OF UNSPECIFIED CHEMOTHERAPY, MFR UNK