MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15" SMALLBORE EXT SET W/MICROCLAVE® (RED RING), 0.2 MICRON FILTER, CLAMP, ROTATI; STOPCOCK, I.V. SET

Catalog Number	B33705
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The reported complaint involved a 15" smallbore ext set w/microclave® (red ring), 0.2 micron filter, clamp, rotating luer that was reported to have a cracked filter.There was no human harm reported.
Additional Manufacturer Narrative
One photo was shared by customer, where is observed the product label with the item and lot number involved in the complaint.The condition reported by customer is not observed.The complaint of cracks cannot be confirmed based photos shared by customer.Due to no filter cracked is observed, since no product sample was received for investigation a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record (dhr) was reviewed and no non-conformities were found that would have led the reported complaint.Updated information can be found in d9 and g1.

• Brand Name: 15" SMALLBORE EXT SET W/MICROCLAVE® (RED RING), 0.2 MICRON FILTER, CLAMP, ROTATI
• Common Device Name: 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: 17623988
• Report Number: 9617594-2023-00598
• Device Sequence Number: 7545264
• Product Code: FMG
• UDI-Device Identifier: 00887709076556
• UDI-Public: (01)00887709076556(17)280401(10)13611140
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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): 08/07/2023

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 Catalogue Number: B33705
• Device Lot Number: 13611140
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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