MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" PRESSURE INFUSION (400PSIG) EXTSET W/REMV MICCLAVE,PURPLE CLAMP, ROTAT LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	B33056
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 7" pressure infusion (400psig) ext set w/remv microclave®,purple clamp, rotating luer.The reporter stated that, after disconnecting iv tubing from the blue occlusive cap at the end of an iv extension set, the blue occlusive cap became dislodged by itself that caused the iv to leak blood.When checked, the occlusive cap had come fully dislodged from the tubing of the iv extension set.The rn occluded the vein, had another rn grab a second set, twisted off the occlusive cap from that set, and used that and a flush to seal and then flush the iv in the patient's arm.It was found from staff in the er that the cap indicated in the statement will sometimes be loose when the item is removed from the packaging and mentioned it was as if it had not been completely screwed onto the tube.There was no adverse event and no delay in therapy.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed.Without the return of the sample or photo/video, an investigation could not be performed and a probable cause could not be determined.A dhr lot # review could not be conducted because no lot number was identified.

• Brand Name: 7" PRESSURE INFUSION (400PSIG) EXTSET W/REMV MICCLAVE,PURPLE CLAMP, ROTAT LUER
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20416220
• Report Number: 9617594-2024-01407
• Device Sequence Number: 15553891
• Product Code: FPA
• UDI-Device Identifier: 00887709006041
• UDI-Public: 00887709006041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 10/10/2024

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: B33056
• Device Lot Number: UNKNOWN
• 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: 09/12/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 IV EXTENSION SET, MFR UNK
• Patient Sex: Unknown