MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ADMIN SET, CLAVE¿, EXT SMALLBORE, 2 NANOCLAVE¿; STOPCOCK, I.V. SET

Catalog Number	011-MC330694
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4, g4: model number is not sold in the us but similar device is sold under model mc330690.This product was used for the di and 501k investigation summary a picture was returned showing the admin set with the nanoclave y-connector broken at the outgoing tubing.The complaint of backflow could be confirmed based on the returned image.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved an admin set, clave¿, ext smallbore, 2 nanoclave¿ , experienced separation and leakage.The following issue was reported by the customer: ¿ materiovigilance incident on july 5th and on july 8th with the tubing".A photo of the device was provided, the photo is showing a tubing connected to a 150ml ultravist 370 ( 370 mg iodine/ml ) solution for injection/infusion iopromide.Update from initial reporter: ¿tubing broke off, the device was not retained but a photo was provided.The tubing was used to inject fdg, to perform the imagining, a part of the tubing was removed, the syringe was connected and the extension to inject the contrast product.The tubing broke off at the first 3cm during the administration of the contrast product at tep 2, blue catheter velocity of 1.8 ml/s.Consequences: no contrast product was injected to the patient, blood reflux with the contamination of the pet scan and the floor with blood.¿ the customer also stated there were no clinical consequences for the patient, the incident occurred during use of the device.

• Brand Name: ADMIN SET, CLAVE¿, EXT SMALLBORE, 2 NANOCLAVE¿
• Common Device Name: 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19956833
• Report Number: 9617594-2024-01121
• Device Sequence Number: 21074504
• Product Code: FMG
• UDI-Device Identifier: 00887709124004
• UDI-Public: 00887709124004
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 011-MC330694
• Device Lot Number: 13929458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CONTRAST (FDG), MFR UNK; UNSPECIFIED SYRINGE, MFR UNK
• Patient Sex: Unknown