MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) APPX 0.25 ML SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/PURPLE C; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	B33158
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation.It has not been received.
Event or Problem Description
The event involved a 5" (13 cm) appx 0.25 ml smallbore pressure infusion (400psig) ext set w/purple clamp, luer lock, drop-in microclave®.The customer reported that the tubing detached at some point between the start and the middle of a patient's infusion.There was no harm associated with the reported event.
Additional Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.The device history record (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The reported complaint cannot be confirmed based on the information that has been provided.

• Brand Name: 5" (13 CM) APPX 0.25 ML SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/PURPLE C
• 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: 13573289
• Report Number: 9617594-2022-00025
• Device Sequence Number: 5527051
• Product Code: FPA
• UDI-Device Identifier: 00887709006546
• UDI-Public: (01)00887709006546(17)260901(10)5609911
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 09/01/2026
• Device Model Number: B33158
• Device Catalogue Number: B33158
• Device Lot Number: 5609911
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED DRUG OR FLUID, MFR UNK
• Patient Sex: Unknown