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 Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.Plot: 13972999 manufacturing date 4/1/2024 expiration date 4/1/2027.Additional reporter: (b)(6).
Event or Problem Description
The event involved a chemosafelock bag spike where it was reported there was leakage.Leakage occurred in between a bag spike and connector during infusion.One actual sample was received connected to a saline bottle (50ml).With ¿as-received¿ condition, we applied pressure to the bottle.No leakage was observed.Upon closely checking the top surface of the connector of the actual sample, no damage was confirmed in the main seal.Connected our in-house kl-msu3 to the ¿as received¿ sample and liquid flow was checked under gravity.Leakage was confirmed at the back of clips of kl-msu3.Ct inspection was performed.The result shows the distortion of conduit near the opening (close to spike side).Kl-at30l1aya was the mating device.Fluorouracil was the medications involved.Kl-at30l1aya was the mating device involved.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.
Additional Manufacturer Narrative
A series of photos were shared by the customer, where a ct inspection of "actual sample" and "good sample" is observed.Where a shadow on the top seal is indicating a seal misalignment a leak from a chemolock is observed.However, the source of the leak is not clear.One used.List #kl-bs001u3, chemosafelock bag spike was returned for evaluation.As received no damage/scratch over the top seal was observed, only a seal misalignment was observed.The sample was primed, and no leak was observed.A new chemolock was connected and a leak at gravity pressure was confirmed.The chemolock was dissembled a deformed spike was observed.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 was performed and no commodities, discrepancies, nonconformances or anomalies were identified, that might lead the condition reported by the customer.D9 device returned to manufacturer on 12/16/2024.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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20929394
• Report Number: 9617594-2024-01785
• Device Sequence Number: 15551392
• Product Code: FPA
• UDI-Device Identifier: 00840619023676
• UDI-Public: 00840619023676
• 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,Distributor
• Initial Reporter Occupation: Pharmacist
• 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: PLOT
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLUOROURACIL, UNK MFR; KL-AT30L1AYA; SALINE BOTTLE(50ML), UNK MFR
• Patient Sex: Unknown