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 Air/Gas in Device (4062)

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

Event Date 12/30/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it has not yet been returned.Initial reporter phone extension- (b)(6).

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 luer.The customer reported that the device does not connect to a catheter (it rotates, but does not connect).Air bubbles were observed and there was a delay in therapy as the device had to be replaced.The event was observed when installing the device; there was patient involvement, no blood loss and no harm reported as a consequence of this event.

Manufacturer Narrative

One used 25 cm (10") pur yellow smallbore ext set, 6-port nanoclave¿ manifold w/check valve, nanoclave¿, 4-way nanoclave¿ stopcock (red ring), rotating luer were returned for evaluation.A photo was returned identifying the spin luer of the nanoclave stopcock as being the focus of the complaint about disconnecting from a catheter.No mating device catheter was returned to evaluate with the 011-am6136 extension set.There was no visible damage or anomalies observed with the returned assembly.The used extension set was evaluated and functionally measured and tested and the male luer connection was iso design compliant and did not result in leakage or air ingress during testing and there was no propensity to disconnect from the mating female luer during testing.Without return of the mating device catheter the complaint was unable to be replicated or confirmed.A device history review could not be conducted because no lot number(s) was/were identified.Additional information d9 - date device received 2/21/23.

• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16264648
• MDR Text Key: 309160615
• Report Number: 9617594-2023-00047
• 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
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• 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: CATHETER, MFR UNK
• Patient Sex: Male
• Patient Weight: 3 KG