MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 18 CM (7") APPX 0.25 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number IA-C3302

Device Problem Material Puncture/Hole (1504)

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

Event Date 10/04/2023

Event Type  malfunction  

Event Description

The incident involved a 18 cm (7") appx 0.25 ml, smallbore ext set w/microclave®, clamp, rotating luer.The reporter stated that there was a silicone returning failure.That there was no reported impact of the event on the patient and medical institution worker.One(1) actual sample was received without the package and evaluated by the distributor.Upon closely checking the connector part, valve returning failure was confirmed and internal spike was exposed.Their in-house three-way cock was connected to the sample and attempted to flow liquid from the three-way cock side.As a result, leakage was observed at the top surface of connector.It was also mentioned that it was not detected prior to direct patient use.The event occurred during infusion.The identity of involved and/or mating devices is unknown.The device(s) was changed out/replaced with no further problems encountered.There was patient involvement but no patient harm.

Manufacturer Narrative

One (1) photo was shared by the customer where a stick down condition is observed on the shuntless and a drop of water is coming from the top.One (1) used sample list #ia-c3302 was returned for evaluation.As received the shuntless came separated from the rest of the set and a stick down condition was confirmed on it.No additional damage or anomalies were observed.The shuntless was dissembled and a slightly bent spike condition and a slit propagation on the seal was confirmed.No mating device was returned for evaluation.Complaint of silicone stick down condition can be confirmed based on the used physical sample evaluation.The probable cause of this condition is unknown.

• Brand Name: 18 CM (7") APPX 0.25 ML, SMALLBORE EXT SET W/MICROCLAVE®, 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: 18310133
• MDR Text Key: 330949016
• Report Number: 9617594-2023-01123
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IA-C3302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• 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