MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM)APPX 15.3ML 20 DROP ADMIN W/MICROCLAVE®, 0.2 MICRON FILTER, FLOW CO; STOPCOCK, I.V. SET

Model Number B9837

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

The device is pending investigation.

Event Description

The customer reported that a 102" (259 cm)appx 15.3ml 20 drop admin w/microclave®, 0.2 micron filter, flow controller, rotating luer was defective.It was further described that the dial-a-flow isn¿t working correctly and the flow rate is too fast.There was patient involvement but there was no harm or delay in therapy.

Manufacturer Narrative

One used 102" (259 cm)appx 15.3ml 20 drop admin w/microclave¿, 0.2 micron filter, flow controller, rotating luer was received and visually inspected.As received, no visible damage or anomalies were observed.No mating devices were returned.The set was primed while the flow regulator was in the open position.Unrestricted flow was established.A flow controller test was conducted and the product met performance specifications.The reported complaint could not be confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 102" (259 CM)APPX 15.3ML 20 DROP ADMIN W/MICROCLAVE®, 0.2 MICRON FILTER, FLOW CO
• 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: 13170407
• MDR Text Key: 290188791
• Report Number: 9617594-2022-00001
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709015890
• UDI-Public: (01)00887709015890(17)260901(10)5607492
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B9837
• Device Catalogue Number: B9837
• Device Lot Number: 5607492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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