MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE¿ CLEAR CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-MC100

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device was discarded and not available for evaluation.However, a photo was provided.The investigation is pending.E1 - (b)(6).

Event Description

The event involved a microclave¿ clear connector where the reporter stated that chemotherapy and hydration leak from the top of microclave despite tight connection on all parts upon investigation.The drug used was intravenous ifosfamide and intravenous mesna.The event occurred halfway during administration of drug.There was no serious injury/death, no blood loss, no adverse operator consequences, and no medical/surgical intervention required.There was unprotected chemo exposure to the to the patient, health care worker or other personnel.The device was changed without further problems encountered.The facility cleaned up as per hospital protocol as the intervention done due to the spillage.Spill kit was used.The set replaced and therapy resumed without any problem.The mating device used was an iv set.There was patient involvement, no patient harm, and no delay in critical therapy.

• Brand Name: MICROCLAVE¿ CLEAR CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18162171
• MDR Text Key: 328426726
• Report Number: 9617594-2023-00997
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: (01)00840619042509(17)280201(10)13561399
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2023

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-MC100
• Device Lot Number: 13561399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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
• Treatment: INTRAVENOUS IFOSFAMIDE, MFR UNK; INTRAVENOUS MESNA, MFR UNK; UNSPECIFIED CHEMOTHERAPY, MFR UNK; UNSPECIFIED IV SET, MFR UNK