MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LU; STOPCOCK, I.V. SET

Catalog Number Z0792

Device Problem No Flow (2991)

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

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

The incident involved a 8" (20cm) appx 0.48ml, smallbore ext set w/0.2 micron filter, clamp, rotating luer on an unknown date.It was reported that the customer had a report of a total parenteral nutrition (tpn) filter occlusion in the neonatal intensive care unit (nicu).There was patient involvement and unknown human harm.This is the first of three reports.

Manufacturer Narrative

The used and one new z0792 extension set assemblies were able to be primed and leak tested without difficulty or leakage.The complaint was unable to be replicated or confirmed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 8" (20CM) APPX 0.48ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LU
• 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: 17744215
• MDR Text Key: 323383871
• Report Number: 9617594-2023-00704
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709021822
• UDI-Public: (01)00887709021822(17)271101(10)11756876
• 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,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: Z0792
• Device Lot Number: 11756876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: TPN, MFR UNK