MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK¿ PORT; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3955
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The event involved a chemolock¿ bag spike with additive port, chemolock¿ port.It was reported that the product was leaking and snapped at the bag port when attaching the circle priming tubing using item #cl3534 (5" (13 cm) appx 1.8 ml, bag spike adapter w/chemolock¿ w/red cap, vented cap, icu medical inc manufacturer).The cl3955 snapped when attaching the cl3534 to the cl3534 side port.The customer was unable to safely save the product as it was contaminated with 100ml of paclitaxel but they can provide a sample of the same lot number of cl3955 and the b braun 100ml 0.9%ns pvc-free bag.It is extremely unsafe for staff to clean this tubing and bag.Although it was reported that there was no patient involvement, the customer also stated that the issue was noticed during / after use and the problem frequency was ongoing for months.There was no patient harm.
Additional Manufacturer Narrative
The following items were provided by the customer for complaint investigation: -one new list# cl3955, chemolock¿ bag spike with additive port, chemolock¿ port, 14062640 -three photographs that confirm the complaint of a broken bag spike.-the used sample and mating device were not returned for evaluation.The investigator verified that the new chemolock¿ bag spike device met all dimensional specifications.Without the return of the used sample, a comprehensive evaluation cannot be performed.The customer complaint of breakage is confirmed from the photographs provided, unable to determine root cause.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in d10, e3, h6 medical device problem code and h6 component code.

• Brand Name: CHEMOLOCK¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOLOCK¿ PORT
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 21611307
• Report Number: 9617594-2025-00487
• Device Sequence Number: 7662619
• Product Code: ONB
• UDI-Device Identifier: 00887709082502
• UDI-Public: (01)00887709082502(17)290701(10)14062640
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131549
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: CL3955
• Device Lot Number: 14062640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: 100ML 0.9%NS PVC, MFR B BRAUN.; 5"13CMAP1.8MLBAGSPKADPTRCHMLCKRDCP LN CL3534MFRICU.; B BRAUN 100ML 0.9%NS PVC.; PACLITAXEL, UNK, MFR.; PACLITAXEL, UNK, MFR.
• Patient Sex: Unknown