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 Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a chemosafelock bag spike where the customer reported that the there foreign material on the spike.The sets were not contaminated with blood or body fluid.There was no reported impact of event on patient and medical institution worker.There were 2 involved defective sets.There was no patient involvement and no harm associated with this event.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
A series of photos were shared by the customer, damage on the spike tip of samples #1 and #2 is shown, and no more anomalies are observed.Two (2) used.List #kl-bs001u3, chemosafelock bag spike were returned for evaluation.As received a lot of unknown dry particulates outside the samples were observed.Also, the spike tip of each sample was bent, and no additional damage or anomalies were observed.No mating device was returned for evaluation.Complaint of spike tip bent can be confirmed.However, based on the small deformation seen this would not affect the functionality of the set.The probable cause of the spike bent condition is unknown.The lot history was reviewed and 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21162752
• Report Number: 9617594-2025-00114
• Device Sequence Number: 9529644
• Product Code: FPA
• UDI-Device Identifier: 00840619023676
• UDI-Public: (01)00840619023676(17)270501(10)14026169
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: KL-BS001U3
• Device Lot Number: 14026169
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/05/2025
• 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
• Patient Sex: Unknown