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 Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

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

Event Date 08/10/2023

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 an air in line towards end of infusion was reported.The event occurred at 1100 involving etoposide.There was patient involvement and unknown patient harm reported.

Manufacturer Narrative

One used sample list #b30183 connected with spiros, a used bd phaseal and a fresenius kabi 0.9% sodium chloride injection usp freeflex 500 ml intravenous bag with durvalumab were returned for evaluation.The inlet and outlet filters appeared to be wetted out.No additional damage or anomaly was observed.The set was primed and purged as per procedure and no leaks along the device, on the bd phaseal connection neither air in line were observed.No air in line were identified after the test.However, complaint of leaks can be confirmed based on the inlet and outlet filters that appeared to be wetted out, nevertheless during the test, leaks couldn¿t be replicated.The probable cause is typical due to 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, 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/
• 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: 17719345
• MDR Text Key: 323065471
• Report Number: 9617594-2023-00677
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709055445
• UDI-Public: (01)00887709055445(17)270901(10)9930806
• 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: Other Health Care Professional
• 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: 09/11/2023
• 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: 9930806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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: 0.9% NACL INJECTION USP FREEFLEX 500ML IV BAG, FK; DURVALUMAB, MFR UNK; ETOPOSIDE, MFR UNK; PHASEAL, BD MFR; SPIROS, MFR UNK