MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED SPIROS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	UNKNOWN
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device/s are available for evaluation- they have not been received.
Event or Problem Description
The event involved an unspecified spiros where the customer reported that they are experiencing the connector starting to unwind itself off a patient ivs.Every time a problem arises with these spiros (which have personally had this situation happen about 4-5 times since we started using the new brand of microclave) is that where the spiros attaches to the microclave itself, it untwists itself without being touched.The majority of the time, it is not a problem, but it is odd when it does happen.So, the piece in the photos would not be of help in the situations they have.Every time it has happened, it is on a cadd pump.The spiros comes out of pharmacy attached to the pump, so no information on the lot number, etc.Upon disconnect it was not coming unscrewed when the tape was removed and there was no evidence of a leak.The event did occur during patient use and there was no harm/adverse event.
Additional Manufacturer Narrative
Received one used list# unknown, extension tubing; one used list# unknown, cassett with tubing; one used list# ch2000, spiros¿ closed male luer.As received, no physical damage or other anomalies observed.Spiros was received activated.Tested with returned mating device, no separation observed.Cannot confirm customer complaint of spiros connector starting to unwind itself.A device history lot# review could not be conducted because no lot number(s) was/were identified.

• Brand Name: UNSPECIFIED SPIROS
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 20049903
• Report Number: 9617594-2024-01175
• Device Sequence Number: 7959645
• Product Code: ONB
• UDI-Device Identifier: 00840619082604
• UDI-Public: 00840619082604
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• 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): 12/10/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 12/10/2024
• 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: CADD PUMP, MFR UNK; MICROCLAVE, MFR UNK
• Patient Sex: Unknown