MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 305 CM (120") APPX 22.2 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, CHECK VALVE,; STOPCOCK, I.V. SET

Catalog Number 011-C6002

Device Problem Defective Device (2588)

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

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

One used list #011-c6002, 305 cm (120") appx 22.2 ml, 20 drop blood set w/200 micron filter, check valve, 2 clave¿ clear, spin luer, lot #5244905 and one photo showing a hair in inside the blood filter chamber were received.The complaint of a hair in the line was confirmed as there was a hair observed inside the blood filter chamber of the returned device.There was no damage or cracks observed on the device.The probable cause of the hair in line is due to a manufacturing-related error.(b)(6).

Event Description

The event involved a 305 cm (120") appx 22.2 ml, 20 drop blood set w/200 micron filter, check valve, 2 clave¿ clear, spin luer that the customer reported to be faulty.During investigation, foreign material (a hair) was identified in the blood filter chamber on the returned used administration set.There was no report of human harm.

• Brand Name: 305 CM (120") APPX 22.2 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, CHECK VALVE,
• 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
• MDR Report Key: 12579928
• MDR Text Key: 282045403
• Report Number: 9617594-2021-00272
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619070519
• UDI-Public: (01)00840619070519(17)260401(10)5244905
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-C6002
• Device Lot Number: 5244905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1