MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 112" (284 CM) APPX 14.4 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B9286
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 112" (284 cm) appx 14.4 ml, 15 drop primary set w/3 microclave®, rotating luer.The report stated that the tubing exploded at the end of the test and the tubing has 2 access ports not 3.The tubing opened about 2.5 inches above the lowest access port.There does not appear to be any blood in the tube.When the patient returned to the ed, the tubing was changed out and the iv was still usable.They only have the tubing itself.No other components.There was no harm to the patient.
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Additional Manufacturer Narrative
One (1) used unknown, extension set with 2 y-claves and back check valve was returned for evaluation.As received, a split tubing was observed close to the distal end of the set, no punctured or stretch damage were observed.No mating device was returned for evaluation.Complaint of tubing burst can be confirmed.The probable cause is unknown.The dhr review couldn't be performed due to the lot number for this complaint was unknown.

• Brand Name: 112" (284 CM) APPX 14.4 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE®, ROTATING LUER
• 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: 19686808
• Report Number: 9617594-2024-00878
• Device Sequence Number: 8130976
• Product Code: FMG
• UDI-Device Identifier: 00840619045876
• UDI-Public: (01)00840619045876
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: B9286
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 07/07/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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