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, I.V. SET

Catalog Number B30183

Device Problem Air/Gas in Device (4062)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

One (1) used sample list #b30183 connected with a used, equashield, and used, bag spike adaptor; lot #unknown and one used.A 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.Complaints of product incorporates/allows air passage cannot be confirmed.However.The probable cause of the leaks coming from the inlet filter is typically a 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 to the reported complaint.

Event Description

It was reported that a 32" (81 cm) appx 6.3 ml, 15 drop admin set w/0.2 micron filter, rotating luer w/filter cap, bag hanger allowed air to enter the tubing, trapping fluid above in the bag and drip chamber during patient use.Then air in the tubing down to the filter and there is fluid below the filter.They are unable to back prime to clear the line of air and run the medicine.The device is contaminated with chemotherapy.There was a patient involved, no patient harm and there was a delay in therapy as the drug had to be remade to complete the therapy.No additional information is available at this time.

• 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, 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: 18947294
• MDR Text Key: 338328699
• Report Number: 9617594-2024-00303
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709055445
• UDI-Public: (01)00887709055445(17)281101(10)13828709
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 13828709
• 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: 12/01/2023
• 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
• Treatment: UNSPECIFIED CHEMO, UNK MFR