MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXTENSION SET, 32 INCH, 2 CLAVE(TM) Y-SITES, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126780451
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event involved an extension set, 32 inch, 2 clave(tm) y-sites, secure lock in which the customer reported that the blood backed up into the extension set and leaked out one of the y site claves.The device was changed out/replaced with no further problems encountered.There was no blood loss, no unprotected chemo exposure and there was no delay in critical therapy.There was patient involvement, however, there was no adverse outcome as a consequence of this event.
Additional Manufacturer Narrative
The initial report was submitted in error; the device was received and evaluation was performed.Blood residuals were observed in the device as received.No other damages or anomalies.The set was leak tested per product specifications.There was no leakage.The reported complaint of backflow was unable to be replicated or confirmed.Lot history review was performed and no relevant non conformities were found that would have led to the reported complaint.

• Brand Name: EXTENSION SET, 32 INCH, 2 CLAVE(TM) Y-SITES, SECURE LOCK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18119501
• Report Number: 9615050-2023-00630
• Device Sequence Number: 20735279
• Product Code: FPA
• UDI-Device Identifier: 10887787006107
• UDI-Public: (01)10887787006107(17)260601(10)13605256
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• 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): 07/24/2024

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 Expiration Date: 06/01/2026
• Device Catalogue Number: 126780451
• Device Lot Number: 13605256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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: UNSPECIFIED MEDICATION, MFR UNK
• Patient Sex: Unknown