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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a chemosafelock bag spike where the customer reported a leakage during infusion.There was no serious injury/death, no blood loss, no unprotected chemo exposure, no delay in critical therapy, no adverse operator consequences, and no med/surg intervention required.The device(s) was changed out/replaced with no further problems encountered.Mating device is kl-af30l1ay.Type of procedure was preparation the medication involved was 5fu.One physical sample was received in the opened package.Upon visually checking the sample, tearing was confirmed on the top surface of main seal.We connected the sample to our in-house saline bottle and applied pressure to the bottle.As a result, leakage occurred at the damaged portion on the top surface of the sample.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Additional Manufacturer Narrative
A series of photos was shared by the customer that illustrate a drop of water coming from a tear over the seal.There were no additional damage or anomalies were observed.The item and lot information are shown in the photos.One used list #kl-bs001u3, chemosafelock bag spike was returned for complaint evaluation.As received, there was a small tear over the top seal, no additional damage or anomalies were observed.The sample was primed and leaks through the tear were observed.Once the device was dissembled, the tear over the seal and a curved/deformed spike were observed.Complaint of leakage can be confirmed.The probable cause is due to a deformation on spike happening due to a conveyer damage during the manufacturing molding process.The probable cause of the tear on the seal is unknown.A dhr lot review, was performed and no relevant commodities, discrepancies, anomalies or nonconformances were identified that might lead to the condition reported by the customer.

• 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: 20692142
• Report Number: 9617594-2024-01615
• Device Sequence Number: 8659322
• Product Code: FPA
• UDI-Device Identifier: 00840619023676
• UDI-Public: (01)00840619023676(17)270401(10)13972993
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173477
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: 13972993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: UNSPECIFIED KL-AF30L1AY, MFR UNK.
• Patient Sex: Unknown