MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 123" (312 CM) APPX 15.8 ML, 60 DROP PRIMARY SET W/BCV-CLAVE®, 2 Y-CONNECTORS W/2; STOPCOCK, I.V. SET

Catalog Number B90027

Device Problem Particulates (1451)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Additional contact: (b)(4).

Event Description

The complaint/event occurred on an unspecified date and involved a 123" (312 cm) appx 15.8 ml, 60 drop primary set w/bcv-clave®, 2 y-connectors w/2 microclave®, 2 check valves, rotating luer.It was stated in the report that there were particles inside the tubing upon opening the package.There was no patient involvement and no patient harm reported.

Manufacturer Narrative

No product samples were returned for investigation, however, a series of photographs were returned showing a drip chamber component of a b90027 primary set assembly with embedded burnt plastic confirmed in the cylinder wall of the drip chamber.Typically, embedded burnt plastic is totally encapsulated within the wall of the plastic component and is not exposed to the fluid path.The probable cause of the encapsulated burnt plastic is typical of a molding anomaly.Without the actual sample, a full complaint investigation could not be performed to substantiate a significant/substantiated conclusion regarding the customer's reported issue and the cause.The dhr for lot 13558820 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: 123" (312 CM) APPX 15.8 ML, 60 DROP PRIMARY SET W/BCV-CLAVE®, 2 Y-CONNECTORS W/2
• 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: 18388871
• MDR Text Key: 331485778
• Report Number: 9617594-2023-01189
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B90027
• Device Lot Number: 13558820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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