MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 1.4 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 0.2 MI; STOPCOCK, I.V. SET

Catalog Number K7056-001

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

The event involved a 7" (18 cm) appx 1.4 ml, smallbore quadfuse ext set w/4 microclave® clear, 0.2 micron filter, 3 check valves, 4 clamps, rotating luer where it was reported that a ¿black flecks noted in filter at 48 hours of use¿.A total parenteral nutrition (tpn) had been infusing via filter.There was patient involvement but no patient harm and no delay of care.

Manufacturer Narrative

Received one used list #k7056-001.7" (18 cm) appx 1.4 ml, smallbore quadfuse ext set w/4 microclave® clear, 0.2 micron filter, 3 check valves, 4 clamps, rotating luer; lot #5262728.As received there was black-brown dots observed in the filter cassette and the complaint was confirmed.The black-brown dots appeared to be on the proximal end of the inner 0.2 micron filter.The filter was dissembled to evaluate.There were no loose particulates inside the filter.The black-brown dots appeared to be saturating the filter.The black-brown spots could not be removed from the filter.The distal end of the filter (back side of the filter) did not have any spots.The black-brown spot did not appear to have flowed downline from the filter.The exact origin of the spots is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" (18 CM) APPX 1.4 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 0.2 MI
• 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: 12469694
• MDR Text Key: 280768246
• Report Number: 9617594-2021-00254
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709036949
• UDI-Public: (01)00887709036949(17)260401(10)5262728
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K7056-001
• Device Lot Number: 5262728
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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: TOTAL PARENTERAL NUTRITION (TPN), MFR UNK.