MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 226 CM (89") APPX 11.2 ML, 20 DROP W/15 MICRON FILTER ADMIN SET W/EASYDROP FLOW; STOPCOCK, I.V. SET

Catalog Number 142339260

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

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

Event Date 03/25/2022

Event Type  malfunction  

Event Description

The event involved a 226 cm (89") appx 11.2 ml, 20 drop w/15 micron filter admin set w/easydrop flow controller, pre-pierced port, rotating luer w/filter cap where it was reported that during a general anesthesia in an orchidopexy procedure, the nurse anesthetist connected a dial-a-flo to the patient for a slow infusion and at the end of the infusion, the dial-a-flo tubing continued to leak.With the infusion empty, the tubing filled with air.The nurse anesthetist realized this and stopped the system, removed the dial-a-flo, and replaced it with a single line.The medication involved was unknown and the procedure was performed under general anesthesia.There was no hole, cut, tear or any other defect visible.There was no medical or surgical intervention required, the clinical impact to the patient was inconsequential, and the device was changed out or replaced with no further problems encountered.There was patient involvement but no harm because the tubing was removed in time and the patient¿s status returned to baseline condition.

Manufacturer Narrative

The device is available for evaluation.It has not been received.

Manufacturer Narrative

Received one used and one new/unused list #142339260, 226 cm (89") appx 11.2 ml, 20 drop w/15 micron filter admin sets w/easydrop flow controller, pre-pierced port, spin luer w/filter cap; lot #5486850 and were visually inspected.As received, the used set was returned with a cracked non-icu medical needle cover placed over the bag spike.The bag spike tip of the used set was also found to be broken.It is unknown how, when or where the damage occurred.No damage or anomalies were identified on the new set.Each sample was leak tested according to product performance specifications.No leakage or air in the lines was observed.Although no leakage or air in the lines was replicated during testing, it is unknown if the broken spike observed would have caused air or leakage without the return of the mating device.The reported complaint could not be replicated or confirmed.The lot history was reviewed and no nonconformities were reviewed that may have contributed to the reported complaint.Additional information found in b5 - describe event or problem.Also, d9 - date returned to mfg is 5/12/2022.

Event Description

New information was received stating that the procedure was performed under general anesthesia.There was no medical intervention done since it was a urology procedure.The procedure took place and was not interrupted and the clinical impact for the patient is inconsequential.

• Brand Name: 226 CM (89") APPX 11.2 ML, 20 DROP W/15 MICRON FILTER ADMIN SET W/EASYDROP FLOW
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14228304
• MDR Text Key: 290474840
• Report Number: 9617594-2022-00105
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619099381
• UDI-Public: (01)00840619099381(17)260701(10)5486850
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 142339260
• Device Lot Number: 5486850
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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 MEDICATION, MFR UNK.