MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 104" (264 CM) APPX 13.4 ML, 60 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER,; STOPCOCK, I.V. SET

Model Number B90108

Device Problem Air/Gas in Device (4062)

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

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event involved a 104" (264 cm) appx 13.4 ml, 60 drop primary set w/3 microclave®, rotating luer, filter cap.It was reported they obtained several air bubbles following the air vacuum.The solute bag used: nacl 0.9% 500ml.There was no report of harm.

Manufacturer Narrative

Two returned new b90108 primary sets were successfully primed at gravity pressure using a flexible infusion bag of 0.45% sodium chloride.There were no bubbles at any location along the fluid path after priming.The complaint was unable to be replicated or confirmed with the new b90108 primary sets.The device history record for lot 6031881 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The product was received 2/15/2023.

• Brand Name: 104" (264 CM) APPX 13.4 ML, 60 DROP PRIMARY SET W/3 MICROCLAVE®, 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16068481
• MDR Text Key: 308538013
• Report Number: 9617594-2022-00342
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B90108
• Device Catalogue Number: B90108
• Device Lot Number: 6031881
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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: NACL 0.9% 500ML, MFR UNK