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	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation- the investigation is pending.
Event or Problem Description
The event involved a chemosafelock bag spike where a leak during infusion was reported.After prepared and connected to the distal end of the line, it was left for 30minutes.When the user attempted to start infusion, they found much amount of solution leaked at the connection.One(1) actual sample was returned connected to a saline bag(otsuka).In addition, chemosafelock infusion set(kl-af30l1aya), and three(3) pcs.Unopened samples of same lot with the actual sample.After connected the sample to our in-house saline bag and the returned chemosafelock infusion set, we checked the liquid flow under gravity.As a result, leakage was confirmed at the connector.For three(3) pcs.Of same lot samples, no leakage was confirmed during the liquid flow check performed under gravity.When we applied pressure on the bag connected to the actual sample, leakage was confirmed at the top surface of the sample.Upon closely checking, damage was confirmed at the main seal.Te-281a, extension tube, i.V.Catheter and kl-af30l1aya are the identified involved mating devices.Preparation was the type of procedure.Paclitaxel was the medication involved.There was no serious injury/death, no blood loss, no unprotected chemo exposure, no delay in critical therapy, no adverse operator consequences and no medical/surgical intervention were required.The device was changed out/replaced with no further problems encountered.Leakage was confirmed at the top surface of the sample.There was no reported impact of event on patient.There was no reported impact on medical institution worker.
Additional Manufacturer Narrative
A series of photos were shared by the customer, where a drop of water is observed coming from a tear over the seal.The sample is observed to be connected with an unknown extension set.One (1) used list #kl-bs001u3, chemosafelock bag spike and one (1) used #unknown, chemolock injector connected into an unknown, infusion set were returned for evaluation.As received a small tear over the top seal was observed, no additional damage or anomalies were observed.The sample was tested as procedure and a leak from between the spike tip and the silicone seal was confirmed.Once the sample was dissembled a curved /deformed spike and the tear seal.Complaint of leakage can be confirmed.The probable cause of the deformed spike happening due to a conveyer damage during molding process.A device history lot review of the possible lot was performed and no discrepancy, anomalies or nonconformances were identified that might be related with the condition reported by the customer.Corrective actions are in process.

• 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: 20842977
• Report Number: 9617594-2024-01724
• Device Sequence Number: 8039417
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: 11/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/14/2025
• 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: CHEMOSAFELOCK INFUSION SET(KL-AF30L1AYA).; IV CATHETER, MFR UNK.; PACLITAXEL, MFR UNK.; SALINE BAG(OTSUKA)..; UNSPECIFIED "TE-281A", MFR UNK.; UNSPECIFIED EXTENSION TUBE, MFR UNK.
• Patient Sex: Unknown