MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.72 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE®, PURP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	B3361
Medical Device Problem Codes	Material Discolored (1170); Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation, it has not been received.Initial reporter name and address: initial reporter phone has an extension number of (b)(6).
Event or Problem Description
The event involved a 7" (18 cm) appx 0.7 ml, pressure infusion (400psig) ext set w/microclave¿, purple clamp, rotating luer where it was reported gunk in the end of the connector when opening the tubing package.It was also reported that the tubing was discolored.There was no patient involvement, no adverse event, no harm reported and no delay in therapy.
Additional Manufacturer Narrative
The device was not received for evaluation.The complaint of black material on the luer of the male luer can be confirmed.Received one photo showing the male luer of the b3361 with black material observed on the tip of the luer.The material is not in the fluid path.As well the tubing appeared to have a brownish discoloration.The tubing was still translucent.The discoloration is consistent with the discoloration from sterilization.Slight discoloration of tubing is a normal result of the sterilization and doesn't affect the safety or sterility of the set.The probable cause of the black material is due to burnt material embedded in the wall of the male luer during the molding process in manufacturing.The device history record (dhr) was reviewed and no non conformities were found that would have led to the reported complaint.Additional information: d9 - device available for evaluation and d9 - date returned to mfg null.

• Brand Name: 7" (18 CM) APPX 0.72 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE®, PURP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 15362313
• Report Number: 9617594-2022-00256
• Device Sequence Number: 14918743
• Product Code: FPA
• UDI-Device Identifier: 00887709008410
• UDI-Public: (01)00887709008410(17)231201(10)3923457
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K941190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: B3361
• Device Catalogue Number: B3361
• Device Lot Number: 3923457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown