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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS CLOSED MALE LUER W/RED CAP SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS CLOSED MALE LUER W/RED CAP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number CH3515
Device Problems Disconnection (1171); Fluid Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 05/01/2020
Event Type  malfunction  
Manufacturer Narrative
The lot number of the device that was in use is unknown. The customer identified four possible lot numbers (plots). The possible lot numbers are 5048777 (expiry date 10/01/2025, mfr date 10/01/2020), 4976303 (expiry date 08/01/2025, mfr date 08/01/2020), 3786928 (expiry date 09/01/2023, mfr date 10/01/2018), 4192530 (expiry date 08/01/2024, mfr date 08/01/2019). The device was not returned for evaluation. Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined. The lot history was reviewed for possible lot numbers and no nonconformities were identified that may have contributed to the reported complaint.
 
Event Description
The customer was not able to report the exact date of the event but indicated it could be one of the following (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, (b)(6) 2020. The event involved a spinning spiros® closed male luer w/red cap that disconnected between the tubing and the spiros spinning cap when the cap was still attached to the clave needleless connector. This resulted in a patient blood loss from a hemoglobin of 8 to 7. 2. There was patient involvement but no adverse event. This is the second of two events reported.
 
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Brand NameSPINNING SPIROS CLOSED MALE LUER W/RED CAP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
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
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key11236246
MDR Text Key254169728
Report Number9617594-2021-00016
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCH3515
Device Lot NumberPLOTS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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