MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOSAFELOCK BAG SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	KL-BS001U3
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A chemosafelock bag spike reportedly leaked at the bag spike when the user attempted to administer drug solution after connecting the device to a chemosafelock infusion set and infusion bag of 5% glucose injection (otsuka).When the clinician checked the liquid flow under gravity after opening the clamp, leakage was confirmed at the connection between the spike and the body.Upon closely checking this connection, a crack was found at the root of the spike.No anomalies such as bending or damage were found on the spike tip that could have contributed to penetration force.No stress marks or dents were observed on the body either.The event was not detected prior to patient use.There was no serious injury/death, no blood loss, no delay in critical therapy, no adverse operator consequences, no unprotected chemo exposure and no medical/surgical intervention were required.The device was changed with no further problems encountered.There was no reported harm to the involved patient.
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.The customer also provided photos of the device in question.A review of the photos is pending.Additional contact: (b)(6).
Additional Manufacturer Narrative
A series of photos were shared by customer, where the spike a small gap in between the spike and chemolock and a drop of water coming out from the same section is observed.One used chemosafelock bag spike and one used chemolock injector were returned for evaluation on 2/11/2026.As received, the chemoport was observed to be tilted and not fully inserted, and a crack at the base was observed.The sample was able to be easily separated, and insufficient solvent coverage was noted in both parts.Complaint of leaks can be confirmed.During the evaluation both components were easily to be separated, the probable cause was due to insufficient solvent coverage applied in manufacturing.Additionally, during investigations a crack on the spike was found, this might happen due to unintentional use condition.Lot history review of the possible lot numbers were reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHEMOSAFELOCK BAG SPIKE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24268277
• Report Number: 9617594-2026-00078
• Device Sequence Number: 18647367
• Product Code: FPA
• UDI-Device Identifier: 00840619023676
• UDI-Public: (01)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: Health Professional
• Device Catalogue Number: KL-BS001U3
• Device Lot Number: UNKNOWN
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 5% GLUCOSE INJECTION, MFR OTSUKA.; UNSPEC. CHEMOSAFELOCK INFUSION SET, MFR ICU MED.
• Patient Sex: Unknown