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 08/07/2023

Event Type  malfunction  

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 generated air in the filter mid-way through infusion.The medication involved was vectibix at 216 ml/hr and the event was noticed at 1250.There was patient involvement and no harm was reported.

Manufacturer Narrative

The complaint that the filter allows air to pass on item b30183 could not be confirmed by the investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) for lot 13490373 was reviewed and no nonconformities were found that would have led 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/
• 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: 17736960
• MDR Text Key: 324020930
• Report Number: 9617594-2023-00698
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709055445
• UDI-Public: (01)00887709055445(17)271201(10)13490373
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• 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: 13490373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: VECTIBIX, UNK MFR