MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" (16 CM) SET DE EXTENSIÓN MICROBORE CON MICROCLAVE¿ CLEAR, FILTRO DE 0.2 MIC; STOPCOCK, I.V. SET

Catalog Number LAT-MC33038

Device Problem Failure to Deliver (2338)

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

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

The device was received for the investigation however testing has not been completed.

Event Description

The event involved a 6.5" (16 cm) set de extensión microbore con microclave¿ clear, filtro de 0.2 micras, luer lock.The reporter stated that two filters were blocked and did not allow the medication amiodarona to pass through.Additionally it was noted that the medication without the filter passed through the tube and with filter did not.There was patient involvement, however there was no one harmed reported as a result of this event.

Manufacturer Narrative

Two (2) used samples list# lat-mc33038 were returned along with a video provided by the end user.As received no physical damage or abnormally were observed in the device.No matting device was returned.The samples were tested at gravity pressure and there was observed flow as expected.Complaint of no flow/can't prime/difficult to prime was not able to confirmed or replicated as seen in the video.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 6.5" (16 CM) SET DE EXTENSIÓN MICROBORE CON MICROCLAVE¿ CLEAR, FILTRO DE 0.2 MIC
• 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: 16746176
• MDR Text Key: 313393251
• Report Number: 9617594-2023-00143
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709096318
• UDI-Public: (01)00887709096318(17)250601(10)4901960
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LAT-MC33038
• Device Lot Number: 4901960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• 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: AMIODARONA, MFR UNK; ICU MEDICAL PLUM A+ INFUSION PUMP; ICU MEDICAL PLUM SET