MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOSAFELOCK BAG SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

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	11/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a chemosafelock bag spike where a leak was reported.The leakage was found after 35minutes passed from when the administration started.One actual sample was received connected to a chemosafelock infusion set.In addition, the individual package, and a saline bag (500ml/fuso) were also received.-with ¿as-received¿ condition, we connected the actual sample to our in-house saline bag and checked liquid flow under gravity.As a result, the leakage was confirmed at the back of clips.-on the other hand, when we performed liquid flow check under gravity after replaced the klbs001u3 to our factory sample, no leakage was observed.-ct inspection was performed on the connection between the actual sample and the kl-msu3 of infusion set, wherein the deformed conduit and a gap between the conduit and seal part were confirmed.The event was noted during infusion of anticancer drug and was not detected prior to direct patient use.There was no serious injury/death, no blood loss, no adverse operator consequences, no unprotected chemo exposure and no medical/surgical intervention were required.The device was changed with no further problems encountered.
Additional Manufacturer Narrative
A series of photos were shared by the customer, a red arrows are pointed to a drops of water that is coming from inside the chemolock.No additional damage or anomalies are observed.One used list# kl-bs001u3, chemosafelock bag spike and one used, unknown, chemo port connected to an unknown, extension tubing with drip charmber were returned for evaluation.As received no physical damage or anomalies were visible observed.The sample was standalone and with the mating device tested and only with the mating device a leak was confirmed.The returned set was cut, and a deformed spike was observed.Complaint of leakage can be confirmed.The probable cause is due to a deformation on spike happening due to a conveyer damage during molding process in manufacturing.A device history report (dhr) lot review was performed and no discrepancies, anomalies were identified that might lead the condition reported by customer.

• Brand Name: CHEMOSAFELOCK BAG SPIKE
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 21406762
• Report Number: 9617594-2025-00312
• Device Sequence Number: 8523746
• Product Code: ONB
• UDI-Device Identifier: 00887709120037
• UDI-Public: (01)00887709120037(17)270401(10)13979997
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131549
• 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
• Report Date (Section B): 02/18/2025

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: 13979997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 02/18/2025
• 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: SALINE BAG (500ML/FUSO), MFR UNK; UNSPECIFIED ANTI CANCER DRUG, MFR UNK
• Patient Sex: Unknown