MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 25 UNITS OF SPIROS® CLOSED MALE LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	011-H2457
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4, g4: model number is not sold in the us but similar device is sold under model z7110.This product was used for the di and 501k.Because the lot# is unknown, the expiration date and manufacturing date are unknown.The device was received 5 aug 2024.Once it has been investigated a supplemental mdr will be submitted.
Event or Problem Description
An event involving 25 units of spiros® closed male luer experienced leakage.The following issue was reported by the customer: ¿we have two cases of leaks concerning the use of spriros : leak at the spriros - needle connection.¿ update : the incident was noticed by the care nurse, who notified the unit pharmacist.The incident happened at the time of connecting the syringe at the start of the infusion: < 1ml of medication.The event happened on (b)(6) 2024.The device was in clinical use at the time of event.The patient was connected to the device but no adverse event and no need of medical intervention.There was a delay in therapy.Destruction of the used syringe and replacement.The medication involved is daratumumab sc (anti corps - cd38 inhibitors).There was a remanufacturing of a new preparation.The medication was changed.The leak occurred from the start of administration.The leak was not cleaned up according to the facility¿s protocol because it was a minimal leak.No visible default on the device before use.No cut, no tear and no hole on the device.
Additional Manufacturer Narrative
No 011-h2457 product samples, videos, or photographs were returned for investigation.The dhr was not reviewed, no lot number information was provided.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 25 UNITS OF SPIROS® CLOSED MALE 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: 19978436
• Report Number: 9617594-2024-01133
• Device Sequence Number: 16839579
• Product Code: FPA
• UDI-Device Identifier: 00887709035904
• UDI-Public: 00887709035904
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: 011-H2457
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/14/2024
• 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: DARATUMUMAB SC, ANTI CORPS.; UNSPECIFIED SYRINGE, MFR UNK.
• Patient Sex: Unknown