MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXTENSION SET, 7 INCH, CLAVE CONNECTOR, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126600490
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.E1 - (b)(6).
Event or Problem Description
The event occurred on an unspecified date(s) and involved an extension set, 7 inch, clave connector, secure lock where the customer reported that when pushing the extension set into high volume, it contracts then blows after.There was patient involvement, a delay in therapy but harm was not reported as a consequence of this event.There were 4 occurrences reported.
Additional Manufacturer Narrative
Device received: 12feb2025.Investigation summary: received four (4) photos showing a used sample with blood.The tubing is ruptured and flared, consistent with a high-pressure injection during use.Received three (3) new list #126600490 extension sets for inspection.No defects or anomalies were observed.The complaint states that "when pushing the extension set into high volume, it contracts then blows after." packaging and dfu state: caution: not for high pressure infusion.The reported complaint can be confirmed based on the photos provided.The probable cause is due to a high-pressure injection on a device that is not rated for high pressure during use.The complaint cannot be confirmed on the unused returned samples.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: EXTENSION SET, 7 INCH, CLAVE CONNECTOR, 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: 21358669
• Report Number: 9615050-2025-00071
• Device Sequence Number: 15562232
• Product Code: FPA
• UDI-Device Identifier: 10887787005612
• UDI-Public: (01)10887787005612(17)270401(10)13948648
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K151969
• Number of Events Summarized: 1
• Summary Report (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): 03/22/2025

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: 126600490
• Device Lot Number: 13948648
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/22/2025
• 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
• Patient Sex: Unknown