MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ADMIN SET, PUR, CLAVE¿; STOPCOCK, I.V. SET

Catalog Number 011-H3940

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however, has not yet been received.

Event Description

The event involved a admin set, pur, clave¿ where it was reported, before the realization of the proton emission tomography (tep) of the patient, a radiopharmaceutical product: [18f] - fluorodeoxyglucose is injected using a tubing from icu medical company.At 14:37, the activity of fdg to be injected is 230 mbq.At 16:20, the residual activity measured in the tubing is 45 mbq.Therefore, considering the radioactive decay of 18-fdg, this means that approximately 86 mbq out of 230 mbq were not injected, which is 37,4% of the intended activity to be injected.The following clinical consequences reported were altered quality of the images of the tep scan, complicating the medical diagnosis.There's an increased patient dosimetry due to the necessity for repeating the examination.For the actions taken for the patient regarding the device, a new consultation was scheduled for the patient to conduct a new imagining examination through tep, considering the alteration of the image's quality from the first examination, using a tubing with the same reference.There was patient involvement, unknown adverse events/human harm.

Event Description

Additional information received on november 20,2023 from (b)(6) stating that there was an alteration of the quality of tep images complicating the medical diagnoses.There was an increase in the patient dosimetry associated with the repetition of the scan.There was no clinically significant loss of blood noted, no exposure to a cytotoxic product.The operator felt a resistance from the device during the injection.(b)(6).(b)(6), 2023.On december 1, 2023, an email was received stating that the patient's health condition was stable, given their concurrent medical conditions and it was not altered by the injection incident.No one was harmed during the incident.The impact of the incident, as stated previously was the repetiton of the scan.

Manufacturer Narrative

The used 011-h3940 admin set was easily primed at gravity pressure prior to leak testing.There was no leakage and no indication of occluded flow.The complaint was unable to be replicated or confirmed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Device returned to manufacturer on 12/14/2023.

• Brand Name: ADMIN SET, PUR, CLAVE¿
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18161064
• MDR Text Key: 328416824
• Report Number: 9617594-2023-00995
• Device Sequence Number: 1
• Product Code: FMG
• 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,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3940
• Device Lot Number: 13595913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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: [18F] - FLUORODEOXYGLUCOSE, UNK MFR