MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC33129
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 4" (10 cm) smallbore bifuse ext set w/2 microclave® clear, 2 clamps, rotating luer where it was reported from neonatal intensive care / pediatrics unit (nicu/peds), that a patient¿s intravenous (iv) line broke off at site level of bifuse.Line immediately clamped and bifuse was changed.There was no blood loss that occurred since the clave remained in place and intact.The device separated between the clave and tubing.Bifuse was saved and new clave in place.The central line remained in place throughout.There was patient involved, no human harm and no medical intervention provided.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.E1 initial reporter facility name: (b)(6) hospital.
Additional Manufacturer Narrative
One used.List #mc33129 was returned for evaluation.As received the shuntless was observed to be separated from the tube and an irregular tear was observed on the tube.However, inside the shuntless a piece of the cut tube was confirmed.No additional damage or anomalies were observed.Complaint of separation can be confirmed based.The probable cause is typical due to unintentional pulling force during use.A device history lot review could not be conducted because no lot number(s) was/were identified.Correction in d4: only di provided as lot number is unknown.D9: device returned to manufacturer on 5/31/2024.

• Brand Name: 4" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, 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: 19340925
• Report Number: 9617594-2024-00617
• Device Sequence Number: 15244431
• Product Code: FMG
• UDI-Device Identifier: 00887709037427
• UDI-Public: 00887709037427
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: MC33129
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL LINE, UNK MFR.
• Patient Sex: Unknown