MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.4 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number B2003

Device Problems Break (1069); No Flow (2991)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation- it has not been received.Additional contact: (b)(6).

Event Description

The event involved a 60" (152 cm) appx 0.4 ml, smallbore ext set w/clamp, rotating luer where it was reported that a patient was brought to magnetic resonance imaging (mri), subsequently, small bore mri tubing was used on all intravenous (iv) lines.En route back from mri, the patient's vasopressin din (b)(4) began alarming downstream occlusion.The staff attempted to unhook the extension tubing.The extension tubing broke and they were subsequently unable to disconnect the line.In this situation, the tubing itself broke while staff were attempting to unscrew the stripped/broken connection point.The patient was therefore without vasopressors for several minutes.The lowest mean arterial pressure (map) recorded was 52.The type of incident/problem was connection problem the customer stated that there were no defects noted on the tubing set before it was used.This tubing is only used during mri, so it was removed/discontinued from the patient, and they resumed the use of regular iv tubing.This particular tubing gets connected to their existing iv tubing and then connected to the patient¿s iv access device.They are required to piece 3 of these sets together to get the length required for a patient to get through an mri machine while the iv pump remains outside the room, as the pumps are not mri compatible.Additionally, the customer stated that the vasopressin medication in the tubing (which is not on their hazardous med list) it was connected to a patient¿s iv lines ¿ there shouldn¿t be any bodily fluids in the line, however it was connected to an iv access port.She was not sure where they draw that line.There was no unexpected or prolonged care.Frequency of the problem was recurring.Invasive procedure was not provided or not applicable.The procedure was iv infusion of vasopressor medication.There was patient involvement and no apparent harm - reached patient/person, inconvenient.

Manufacturer Narrative

D9 - date returned to mfg on 12/29/2023.One (1) photo was shared by the customer, where a tubing break from one of the end of the set is observed, the missing part is no observed on the photo.No additional damage or anomalies were observed.Three (3) used sample list #b2003 connected to one (1) unknown extension set were returned for evaluation.As received a tubing break from one of the sample #b2003 was observed, additional the female adaptor was confirmed to be missing, no additional damage or anomalies were confirmed.No mating device was returned.Complaint of tubing break can be confirmed.The probable cause is typical of an unintentional puling force applied during use.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 60" (152 CM) APPX 0.4 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER
• 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: 18436308
• MDR Text Key: 332645342
• Report Number: 9617594-2024-00005
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: B2003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: IV PUMP, MFR UNK.; VASOPRESSIN DIN (B)(4), MFR UNK.