MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 25 CM (10") PUR YELLOW SMALLBORE EXT SET, 6-PORT NANOCLAVE MANIFOLD W/CHECK VAL; STOPCOCK, I.V. SET

Catalog Number 011-AM6136

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

Event Description

The event involved a 25 cm (10") pur yellow smallbore ext set, 6-port nanoclave¿ manifold w/check valve, nanoclave¿, 4-way nanoclave¿ stopcock (red ring), rotating luerin the neonatal ward of the hospital during an infusion of dobutamine which was reported to have leaked.The device was put in place on july 12th and the next day a leak was observed at the fitting between the valves and the extension.The nurse then noticed that the fitting rotates when it should be fixed.The patient was considered unstable and treated with dobutamine.The reporter stated that they do not usually change the device for these patients in order to avoid any hemodynamic repercussions.Hemodynamic impact was observed but considered not serious.The medical team was able to react quickly and change the device so as to minimize clinical consequences.The device was replaced with a new one.No further issues were reported.There was a slight delay in therapy caused by the changing of device.The device was changed and the patient's hemodynamic constants were closely monitored.The patient remained stable on dobutamine before and after changing the device (slight hemodynamic repercussions during the change).There was patient involvement, but no harm was reported as a consequence of this event.

Manufacturer Narrative

One used list# (b)(4), 25 cm (10") pur yellow smallbore ext set, 6-port nanoclave¿ manifold w/check valve, nanoclave¿, 4-way nanoclave¿ stopcock (red ring), rotating luer.Lot# unknown was received for evaluation on 8/16/21.As received there were residuals observed between the male luer of the manifold and the female luer of the extension tubing.The female luer was not fully engaged with the male luer of the manifold.The female luer was still bonded to the male luer of the manifold.The male and female luer could be rotated.There were no other damages or anomalies noted.The set was leak tested per procedure and a channel leak was observed from the connection of the male luer manifold and female luer.The complaint of leakage can be confirmed on the returned unit; the probable cause of the leak is due to an incomplete insertion of the female luer before the bonding process at the manufacturing site.A device history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 25 CM (10") PUR YELLOW SMALLBORE EXT SET, 6-PORT NANOCLAVE MANIFOLD W/CHECK VAL
• 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
• MDR Report Key: 12253315
• MDR Text Key: 264515869
• Report Number: 9617594-2021-00218
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-AM6136
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DOBUTAMINE, MFR UNK
• Patient Age: 2 DA
• Patient Weight: 4