MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 127" (323 CM) APPX 8.9 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO; STOPCOCK, I.V. SET

Catalog Number	B33351
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used list# b33351 connected into a, 0.9% sodium chloride injection usp 250ml baxter iv bag and one used 20ml bd syringe with the tip completely broken connected with the microclave of the set #b33351 were returned for evaluation.As received the broken piece of syringe was easily removed from the syringe, some stress withing marks were observed on both broken pieces, however no solvent or any anomaly was observed.Complaint of tubing dislodged cannot be confirmed, since there no tube connection/disconnection in the returned icu medical set were observed.The returned 20 ml bd syringe is a non-icu medical set therefore the probable cause cannot be determined.A device history lot# review could not be conducted because no lot number(s) was/were identified.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved a 127" (323 cm) transfer set w/dual check valve, microclave® where it was reported that the tubing dislodged during infusing of total parenteral nutrition (tpn) and lipids medication.There was patient involvement, no patient harm and slight delay due to having to perform a cap change and change intravenous (iv) tubing.

• Brand Name: 127" (323 CM) APPX 8.9 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO
• 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: 20909288
• Report Number: 9617594-2024-01763
• Device Sequence Number: 7825427
• Product Code: FMG
• UDI-Device Identifier: 00887709007758
• UDI-Public: 00887709007758
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 12/11/2024

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: B33351
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/11/2024
• 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: TOTAL PARENTERAL NUTRITION AND LIPIDS, UNK MFR
• Patient Sex: Unknown