MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 22 CM (8.5") APPX 0.45 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/2 MIC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-MC330253

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/27/2023

Event Type  malfunction  

Event Description

The event involved a 22 cm (8.5") appx 0.45 ml, smallbore pressure infusion (400psig) ext set w/2 microclave¿ clear, y-connector, clamp, rotating luer that was reported to have leaked.Customer also mentioned stated "they administer chemotherapy drugs which are cytotoxic in nature, rendering the nurses to unnecessary exposure to these agents when leakages occur.We replaced and changed the whole lot to a new lot to them¿.The event occurred during priming, and infusion and flushing.Mating device used was a syringe.The device was changed without further problems encountered.There was patient involvement, no report of patient harm and no delay in critical therapy.There was chemotherapy exposure and the spillage was cleaned up per facility protocol and they open another new piece.When asked about the status of the patient, health care worker or other personnel due to the exposure, the reporter stated "health care worker is ok".Both patient and health care worker were exposed to chemotherapy.This is the seventeenth of 20 reported events.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Additional contact information: (b)(6).

Manufacturer Narrative

The device was not available for investigation.Without the return of the device a probable cause is unable to be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Correction d9 changed from yes to no.

• Brand Name: 22 CM (8.5") APPX 0.45 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/2 MIC
• 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: 17670010
• MDR Text Key: 322491582
• Report Number: 9617594-2023-00641
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619091958
• UDI-Public: (01)00840619091958(17)271201(10)13478046
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K100576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC330253
• Device Lot Number: 13478046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: UNSPECIFIED CHEMOTHERAPY DRUG, MFR UNK.; UNSPECIFIED SYRINGE, MFR UNK.