MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" ADD-ON SET W/CHEMOLOCK® W/RED CAP, DRY SPIKE ADAPTER; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3958
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 6.5" add-on set w/chemolock® w/red cap, dry spike adapter.The report stated that the junction where the white portion of the adapter that connects to the clear tubing is where the leaking was coming from.The nurse went to check her lines and it was very wet and leaking.No chemotherapy was running, luckily it was just primed with normal saline in preparation for chemotherapy so there was no apparent harm to patient, staff and no chemotherapy spill.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
The complaint on the cl3958 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.
Additional Manufacturer Narrative
Received one (1) used cl3958 primary set for inspection.No defects or anomalies noted upon initial inspection.The set was leak tested per product specifications.There was a channel leak from the tubing to the dry spike adaptor connection.Examination of the bond area showed that the bond was not concentrically sealed.The reported complaint of leaks can be confirmed.The probable cause is due to a manual bonding.The device history review could not be reviewed due to the unknown lot number.D9: device returned to manufacturer on: 8/28/2024.

• Brand Name: 6.5" ADD-ON SET W/CHEMOLOCK® W/RED CAP, DRY SPIKE ADAPTER
• 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: 20081796
• Report Number: 9617594-2024-01220
• Device Sequence Number: 15343946
• Product Code: ONB
• UDI-Device Identifier: 00887709083257
• UDI-Public: 00887709083257
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: CL3958
• Device Lot Number: UNKNOWN
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/04/2024
• 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: NORMAL SALINE, MFR UNK
• Patient Sex: Unknown