MAUDE Adverse Event Report: ICU MEDICAL MANUFACTURING JELCO SAF-T HOLDER W/LUER ADAPTER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	96000
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was stuck at the end of the central line, and it broke apart when the nurse unscrewed it.Reporter stated that a patient had to have their central line replaced because they could not remove the broken plastic from the end of his line.The outcome of the event is unknown.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2025-00220.The date of that submission was 23-may-2025.H3: the device history record of reported lot number 6097432 was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the complaint will be reopened for further investigation.

• Brand Name: JELCO SAF-T HOLDER W/LUER ADAPTER
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): ICU MEDICAL MANUFACTURING; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22507212
• Report Number: 3012307300-2025-08353
• Device Sequence Number: 13077630
• Product Code: JKA
• UDI-Device Identifier: 20351688062953
• UDI-Public: (01)20351688062953(17)300226(10)6097432
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K923090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 96000
• Device Lot Number: 6097432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown