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 Contamination (1120)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

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.The customer reported that the set was opened from the packaging and was about to be used when someone noticed what appeared to be ink spots on the end of the set.The product was put back into packaging and was not used.There was no patient involvement, unknown delay in therapy and no patient harm.

Manufacturer Narrative

One (1) open/unused.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 #6877791 was received for evaluation on (b)(6) 2023.A series of photos were returned showing the male spin luer at the distal end of a 011-c6002 set with what appears to be embedded burnt plastic.A 011-c6002 blood set was returned with the male luer at the distal end of the set with embedded burnt plastic that is not in the fluid path.The embedded burnt plastic does not meet visual acceptance criteria.The probable cause is embedded burnt plastic during molding process in manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18253638
• MDR Text Key: 329562955
• Report Number: 9617594-2023-01062
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619070519
• UDI-Public: (01)00840619070519(17)270701(10)6877791
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2023
• 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: 6877791
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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