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

Catalog Number CH3515

Device Problems Disconnection (1171); Fluid/Blood 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.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER W/RED CAP
• Type of Device: SET, 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 Key: 11236246
• MDR Text Key: 254169728
• Report Number: 9617594-2021-00016
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH3515
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2020
• 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
• Patient Sequence Number: 1