MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	206680490
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: no product samples, pictures, or videos were received for investigation.The complaint of tip of the filter spinning off/broke off from the component as a whole but the middle of it still being attached to the blue cap could not be confirmed by investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.H10: additional related record: 9615050-2024-00444.
Event or Problem Description
I was reported there was breakage at the connection of an extension set, 17 inch, 0.2 micron filter, clave(tm) y-site, secure lock.There was patient involvement but no patient harm.Per medwatch: "registered nurse (rn) went to disconnect patients line for labs, and when rn tries to untwist the blue cap from the primary tubing, the tip of the filter spun off/broke off from the component as a whole but the middle of it was still attached to the blue cap.If rn continued to pull it apart, it would have broken and stayed stuck inside the blue cap.The filter that was attached to the primary tubing is a temporary supply, different from our stock.Rn ended up replacing the blue cap and lines with our regular chemo filter.The item listed is the defective/broken product, the nurse then used our chemotherapy filter product as a replacement since the above product was what she found defective.Extension set 17in (0.2) micron filter, clave y site secure lock." per medwatch mandatory report uf/importer # (b)(4).
Additional Manufacturer Narrative
Correction: h10 adding medwatch report (b)(4).D8: was device serviced by third party? no.

• Brand Name: EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, 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: 19581410
• Report Number: 9615050-2024-00483
• Device Sequence Number: 20680567
• Product Code: FPA
• UDI-Device Identifier: 10887787005919
• UDI-Public: (01)10887787005919(17)261101(10)13763281
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151969
• 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): 07/09/2024

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: 206680490
• Device Lot Number: 13763281
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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
• Patient Age: 15 YR
• Patient Sex: Female