MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SURPLUG® MICRO CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number IR-1S

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

One used surplug¿ micro clear was received for evaluation; no foreign matter was identified on the sample.A series of photographs were provided; the observed particulate can be confirmed, however the source of the particle is unknown.The device history review could not be conducted because no lot number(s) was/were identified.

Event Description

The event involved a surplug micro clear that was reported to be broken.The reporter stated that when the user opened the individual package at the hospital ward, he/she noticed that the valve was recessed.It was further reported that the valve edge was fixed and partial gap was confirmed.The internal conduit tip was said to be exposed and visible.Around the conduit exposed portion, valve tearing was observed/confirmed by the customer.No scratches or damages were observed in the housing.Red foreign substance was identified on the inner surface of tip part.The customer reported that upon checking the blood reaction, the result shows positive the device was changed out/replaced with no further problems encountered.The event occurred during patient use; however, no harm was reported as a consequence of this event.

• Brand Name: SURPLUG® MICRO CLEAR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 15293188
• MDR Text Key: 305541496
• Report Number: 9617594-2022-00246
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IR-1S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• 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