MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 32" (81 CM) APPX 6.3 ML, 15 DROP ADMIN SET W/0.2 MICRON FILTER, ROTATING LUER W/; STOPCOCK IV SET

Catalog Number B30183

Device Problem Air/Gas in Device (4062)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

The event involved a 32" (81 cm) appx 6.3 ml, 15 drop admin set w/0.2 micron filter, rotating luer w/filter cap, bag hanger where the customer reported that air entered the tubing, trapping fluid above in the bag and drip chamber then air in the tubing down to the filter and there¿s fluid below the filter.The customer reported that they are unable to back prime and clear the line of air and run the medicine.The customer reported that there was patient involvement but no patient harm and that there was delay in therapy as they needed to rework and reprime to get the entire dose to run.

Manufacturer Narrative

One (1) used sample list #b30183 connected with an used, equashield, an used, bag spike adaptor; lot #unknown and one used.0.9% sodium chloride 500ml bag was returned for evaluation.As received the inlet filter appeared to be wetted out.No additional damage or anomalies were observed.The set was primed and purged as per procedure and a leak coming from the inlet filter vent was confirmed.However, no air beyond the outlet filter vent to the patient line was confirmed.Complaint of product incorporate, allows air passage can be confirmed because, the primary filter has a tear in the filter that may lead to air leakage into the line.The probable cause of the torn observed on the primary filter is unknown.The probable cause of the leaks coming from inlet and outlet filter vents is typical of temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.The lot history was reviewed and no nonconformities were identified that may have contributed tot he reported complaint.

• Brand Name: 32" (81 CM) APPX 6.3 ML, 15 DROP ADMIN SET W/0.2 MICRON FILTER, ROTATING LUER W/
• Type of Device: STOPCOCK IV 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: 18937592
• MDR Text Key: 338201236
• Report Number: 9617594-2024-00297
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709055445
• UDI-Public: (01)00887709055445(17)281101(10)13814425
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B30183
• Device Lot Number: 13814425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2023
• 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