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, LUER SLIP; STOPCOCK, I.V. SET

Catalog Number IA-C3301

Device Problem Material Puncture/Hole (1504)

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

Event Date 09/28/2023

Event Type  malfunction  

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-c3301 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 it was confirmed a slightly bent condition on spike an a slithering propagation on the seal.No additional damage were confirmed.No mating device was returned.Complaint of silicone stick down can be confirmed based on the used physical sample evaluation.The probable cause is typical of slitter damage during assembly in salt lake city the lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Additional contact: (b)(6).

Event Description

The incident involved a 18 cm (7") appx 0.25 ml, smallbore ext set w/microclave, clamp, luer slip.The reporter stated that there was a silicone returning failure.There was no reported impact of event on patient and medical institution worker.The distributor performed an in house evaluation.One(1) actual sample was received without the package.Upon closely checking the connector part, valve returning failure was confirmed and internal spike was exposed.The distributor's 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.The event was not detected prior to patient use.The event was noted during infusion.There was patient involvement and no patient harm.

• Brand Name: 18 CM (7") APPX 0.25 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, LUER SLIP
• 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: 18310297
• MDR Text Key: 330279229
• Report Number: 9617594-2023-01124
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619099213
• UDI-Public: (01)00840619099213(17)280101(10)13527917
• 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-C3301
• Device Lot Number: 13527917
• 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
• Date Device Manufactured: 03/01/2023
• 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