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	11/01/2024
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.The involved and/or mating devices is chemosafelock infusion set.Type of procedure is preparation and medication involved is keytruda.As per report, "one(1) actual sample was returned connected to a saline bag (100ml/otsuka).With ¿as-received¿ condition, when we applied pressure to the saline bottle, no leakage was observed.After connected the sample to the saline bottle, and our in-house kl-msu3, liquid flow as checked under gravity.As a result, the solution was confirmed to be leaking from the back of kl-msu3¿s clips.Upon closely checking of the top surface of the sample, damage was confirmed on the main seal part.There was no reported impact of the event on patient and medical institution worker.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
The following was provided by the customer for complaint investigation: -one used list# kl-bs001u3, chemosafelock bag spike; lot# 13972993 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 into an infusate bag.As received, there was a small tear over the top seal observed on the returned device; no additional damage or anomalies were observed.The sample was tested and a leak from the spike tip and the silicone seal was confirmed.Once the sample was dissembled, a curved/deformed spike and a torn seal was confirmed.This passed to the outer seal, but not in the inner seal.The customer's complaint of leakage was confirmed.The probable cause of the deformed spike happening due to conveyer damage during molding process of manufacturing.

• 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: 20842940
• Report Number: 9617594-2024-01723
• Device Sequence Number: 20818720
• 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): 01/15/2025

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: 01/15/2025
• 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: KEYTRUDA, MFR.; SALINE BAG (100ML/OTSUKA).
• Patient Sex: Unknown