MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL3931
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used list # cl3931, 8.5" (22 cm) appx 1.0 ml, ext set w/microclave¿ clear, chemolock¿ port, spiros¿ w/red cap, clamp; (lot #5000397) was received for evaluation and visually inspected.As received, axial cracks were observed on the exterior of the male luer collar of the bonded male luer adaptor/spiros subassembly.Axial cracks were also present on the female luer of the bonded spiros.No additional damage or anomalies were identified.No mating devices were returned.A functional test was performed; the returned set was primed with water at gravity pressure and then leak tested per procedure.Slight fluid accumulation occurred in between the luer threads of the bonded spiros and male luer adaptor was observed.No other leakage was seen from the set.A photo was provided and evaluated.The photo shows one extension set in a plastic biohazard bag.No visible damage or anomalies can be seen in the image.A lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.The reported complaint of leakage can be confirmed.The probable cause of the cracks on the spiros female luer and the bonded male luer adaptor is likely due to unknown external impact force.
Event or Problem Description
The event involved a 8.5" (22 cm) appx 1.0 ml, ext set w/microclave® clear, chemolock¿ port, spiros® w/red cap, clamp.It was reported that on the patient¿s 5th, and last, day of r-epoch the device was leaking from the spiros end onto the patient's bed.The chemotherapy infusing was doxorubicin, etoposide and vincristine.The patient, and area, were cleaned up per the customer's protocol.The chemo spill was cleaned up per facility protocol.The spiros was connected to the baxter onelink on patient's portal.Therapy was ended; there was no blood loss or bleed back.No holes were noted on the device.There was patient involvement, but there was no adverse event or harm associated with the reported event.

• Brand Name: 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS
• 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
• MDR Report Key: 11751932
• Report Number: 9617594-2021-00143
• Device Sequence Number: 4138770
• Product Code: ONB
• UDI-Device Identifier: 00887709077201
• UDI-Public: (01)00887709077201(17)250901(10)5000397
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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 Expiration Date: 09/01/2025
• Device Model Number: CL3931
• Device Catalogue Number: CL3931
• Device Lot Number: 5000397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1