MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. Jelco Saf-T Wing Blood Collection and Infusion Set; Needle, Hypodermic, Single Lumen

Catalog Number	982312
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction

• Brand Name: Jelco Saf-T Wing Blood Collection and Infusion Set
• Common Device Name: Needle, Hypodermic, Single Lumen
• Manufacturer (Section D): ICU Medical Healthcare Manufacturing S.A. de C.V.; ave calidad no. 4, parque; tijuana NA 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50503288
• Report Number: 9617604-2026-00384
• Device Sequence Number: 9459899
• Product Code: FMI
• UDI-Device Identifier: 20351688060003
• UDI-Public: (01)20351688060003(17)301112(10)6155484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K895705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: Other
• Device Catalogue Number: 982312
• Device Lot Number: 6155484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/28/2026
• 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