MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 328 CM (129") APPX 10 ML, 20 DROP W/15 MICRON FILTER PRIMARY STANDARDBORE/PUR CO; STOPCOCK, I.V. SET

Catalog Number 011-H3854

Device Problems Backflow (1064); No Flow (2991)

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

The event involved a 328 cm (129") appx 10 ml, 20 drop w/15 micron filter primary standardbore/pur coiled smallbore set w/microclave®, 2 check valves, rotating luer.It was reported that the incident occurred on week 24/25 at purpan.At the moment of injection of the radio pharmaceutical medication ( via the "y" injection site), the radiologic technologist observed an increase in liquid level at the drip chamber( chamber located below the puncture site).This increase in level indicated a reflux of the injected product into the tubing, rather than toward the patient.No significant clinical consequences for the patient, but lower quality imaging examination.Conservative measures and actions taken: the radiologic technician immediate response was to squeeze the nacl bag to promote the flow of the radioactive solution toward the patient.Afterwards, the radiologic technician alerted the radio pharmacists.The status of the product at the time of event is during the injection of a radio pharmaceutical drug.There was patient involvement, no adverse events/human harm.The patient did not need an additional medical intervention as the patient received a reduced dose with the examination being successful.There was no delay in therapy.The therapy was successful.No notable clinical consequences, the imaging examination was of slightly lower quality but still interpretable.No spillage of dangerous products, other than the product the patient should have received.No issues to be reported with the patient condition before, during or after the incident.No physical defects noted before or after the incident.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Manufacturer Narrative

One (1) used sample list #011-h3854 connected into an unknown, chlorure de sodium 0,9% viaflo baxter 250 ml intravenous were returned for evaluation.No additional damage or anomalies were observed.The back flow resistances of both check valves was tested and no backflow was observed.Complaint of backflow was not able to confirmed or replicated.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Device returned :10/16/2023.

• Brand Name: 328 CM (129") APPX 10 ML, 20 DROP W/15 MICRON FILTER PRIMARY STANDARDBORE/PUR CO
• 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: 17902259
• MDR Text Key: 325575561
• Report Number: 9617594-2023-00816
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619093693
• UDI-Public: (01)00840619093693(17)270901(10)9297758
• 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
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3854
• Device Lot Number: 9297758
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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: NACL, MFR UNK; RADIO PHARMACEUTICAL MEDICATION, MFR UNK