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	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a chemosafelock bag spike where a leakage was reported.The use of the actual sample was after use.The set was not contaminated with blood or body fluid.There was no reported impact of the event on the patient or the medical institution worker.In addition, the customer stated that the leakage occurred in between a bag spike and an infusion line.One actual sample was received connected to a saline bottle(otsuka/100ml) and an infusion set.- we removed the actual sample from the saline bottle and connected to our in-house saline bottle to perform liquid flow check under gravity.The result recorded leakage at the back side of clips of chemosafe connector.- after changed the returned sample to our inhouse kl-bs001u3 to check the liquid flow under gravity, no leakage was observed.- ct inspection was performed.The result recorded deformed conduit and a gap between the seal part and conduit.- no damage was observed on the main seal part.When we applied pressure solely on the actual sample, no leakage was observed.The event was detected prior to patient use.The event was noted during infusion.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.Same lot device sample is not available.Mating device is not available to be tested.1 involved defective set and 1 actual sample is available for investigation.Sample pictures of a set attached to an iv bottle have been provided.
Additional Manufacturer Narrative
The possible lot numbers are 13979995 (mfr date: 04/01/2024, exp date: 04/01/2027) or 13972999 (mfr date: 04/01/2024, exp date: 04/01/2027).The device was received for evaluation.The investigation is pending.
Additional Manufacturer Narrative
A series of chemolock's photos were shared by the customer, where a leak of water is coming from one of the chemolock's ribs, no additional damage or anomalies are observed.One (1) used list #kl-bs001u3, chemosafelock bag spike connected to an unknown, chemolock injector and infusion set were returned for evaluation.As received no physical damage or anomalies were observed.The returned set was tested as returned configuration and leaks coming from inside was confirmed.The set was standalone test and a leak was observed.The set was cut a spike deformed was found, no additional damage or anomalies were found.Complaint of leak can be confirmed.The probable cause is due to a deformation on spike happening due to a conveyer damage during molding in manufacturing.Lot history review was performed and no discrepancies, anomalies or nonconformances were identified that might lead the condition reported by the customer.

• 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: 21102030
• Report Number: 9617594-2025-00032
• Device Sequence Number: 8818560
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/13/2025
• 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: SALINE BOTTLE(OTSUKA/100ML).; UNSPECIFIED INFUSION SET, MFR UNK.
• Patient Sex: Unknown