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	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.
Event or Problem Description
The event involved chemosafelock bag spike where the customer reported, to terumo, that a leak occurred during patient infusion.There was no reported impact of the event on the patient and medical institution worker.The customer returned one sample to terumo for evaluation.When terumo performed liquid flow check under gravity after connected the sample to our in-house saline bag and the returned infusion set(kl-af3h01y), leakage was confirmed at the back of clips of chemosafe lock connector.After, changed the sample to their in-house kl-bs001u3, liquid flow was checked under gravity and no leakage was observed.Ct inspection was performed.The result recorded deformed conduit and a gap between the seal part and conduit.The reported issue was considered to be a production-origin issue, based on terumo's sample evaluation results.There was no serious injury or death, no blood loss, no unprotected chemo exposure, no delay in critical therapy, no adverse operator consequences, and no medical or surgical intervention required.The device was changed out or replaced with no further problems encountered.
Additional Manufacturer Narrative
A series of photos were shared by the customer, where a red arrows are pointed a drops of water coming from inside the chemolock, no additional damage or anomalies were found.One (1) used list #kl-bs001u3, chemosafelock bag spike with two (2) used unknown, infusion set were returned for evaluation as a mating device, no physical damage or anomalies were observed.The sample was primed with the returned mating device and standalone and a leak was observed.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.Lot history review was performed and no discrepancy, anomalies or nonconformances were identified that might lead the condition reported to 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21034934
• Report Number: 9617594-2024-01883
• Device Sequence Number: 4120222
• Product Code: FPA
• UDI-Device Identifier: 00840619023676
• UDI-Public: (01)00840619023676(17)270401(10)13950531
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Pharmacist
• 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: 13950531
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/12/2025
• 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: CHEMOSAFELOCK INFUSION SET, ICU MEDICAL; PACLITAXEL, MFR UNK
• Patient Sex: Unknown