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
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem 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 it was reported that air entered the tubing, trapping fluid above in the bag and drip chamber.There was also air in the tubing down to the filter and there was fluid below the filter.It was stated they were unable to back prime and clear the line of air to run the medicine.There was patient involved and a delay in therapy due to having to reprime.Some medication was not able to be administered due to issues with the tubing.No report of harm was reported.
Additional Manufacturer Narrative
One used sample list #b30183 connected with a used, equashield, a used, bag spike adaptor; lot #unknown and one used.0.9% sodium chloride 500ml bag was returned for evaluation.No additional damage or anomalies were observed.The set was primed and purged as per procedure and no leaks or anomalies were confirmed.No air beyond the outlet filter vent to the patient line was confirmed.Complaint of product incorporate / allows air passage cannot be confirmed or replicated.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 32" (81 CM) APPX 6.3 ML, 15 DROP ADMIN SET W/0.2 MICRON FILTER, ROTATING LUER W/
• Common Device Name: 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: 18920769
• Report Number: 9617594-2024-00276
• Device Sequence Number: 17692644
• Product Code: FMG
• UDI-Device Identifier: 00887709055445
• UDI-Public: (01)00887709055445(17)281101(10)13814425
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMOTHERAPY, UNK MFR
• Patient Sex: Unknown