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	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
It was reported that the chemosafelock bag spike adapterhad a leak issue.It was stated that there was ¿leakage" observed.The event occurred after use.The sample is not contaminated with blood or body fluid.There was no reported impact of event on patient.There was no reported impact on medical institution worker.The affected sample is available to be sent for investigation.There was unknown patient involvement but no patient harm.
Additional Manufacturer Narrative
A series of photos were shared by the customer, where red arrows are pointed to a drop of water coming from inside the chemolock, no additional damage or anomalies were found.One (1) used list #kl-bs001u3, chemosafelock bag spike was returned for evaluation.As received the seal seems to be a little off center.However, no additional damage or anomalies were observed.No mating device was returned for evaluation.The sample was primed with a chemosafe lock and standalone and a leak in each situation was confirmed.The returned chemoport 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.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
Additional information was received stating that the suspected lot number is 13988483.The customer returned the device to terumo factory and it was reported "leakage at the connection between the concerned product and a chemosafelock infusion set.One (1) actual sample was received connected to a palonosetron i.V.Infusion bag.In addition, chemosafelock infusion set (kl-af3h01n) was also received.No damages or deformation were confirmed, including the main seal.When we connected the sample to our in-house saline bag and chemosafelock infusion set to check liquid flow, leakage was confirmed at the back of clips of chemosafelock connector.When we checked liquid flow after replaced the sample to our in-house kl-bs001u3, no leakage was observed.Ct inspection was performed on the connection between the sample and a kl-msu3, wherein the deformed conduit and a gap between the conduit and seal part were confirmed.The event occurred during infusion of : palonosetron i.V.Infusion bag ¿taiho¿ 50ml.Chemosafelock infusion set(klaf3h01n) was the identified mating device.Type of procedure is drug infusion.The event was not detected prior to direct patient use.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." there was patient involvement but no patient harm reported as a consequence of this event.

• 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: 21127231
• Report Number: 9617594-2025-00055
• Device Sequence Number: 6825523
• Product Code: FPA
• UDI-Device Identifier: 00840619023676
• UDI-Public: (01)00840619023676(17)20170401(10)13988483
• 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): 02/12/2025

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: 13988483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown