MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.9 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK AD; CLOSED TRANSFER SYSTEM DEVICE

Model Number	CL4130
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was reported to be unavailable to be returned to the manufacturer for further investigation.
Event or Problem Description
It was reported that a big spill of adriamycin occurred during an infusion using a chemolock transfer device.It was reported that the spike dislodged from the bag.Once the device is spiked into the fluid bag and rotated on the line where the circle is below, the fluid starts leaking out.The reporter stated while trying to unclip the blue part to prime and administer the drug the spike completely came out of the iv.There was a reported 80 mls of adriamycin to spill.The healthcare provider was reported to be wearing full chemotherapy administration protective equipment.A small amount was reported to have spilled onto the healthcare provider's shoes.The healthcare provider was reported to have changed into clean shoes.The chemo spill was reportedly cleaned per protocol and a spill kit was used.The tubing was said to be replaced with the bag of chemotherapy then the tubing and bag were disposed of into a chemotherapy bin.The pharmacy prepared another bag of chemotherapy.There was no report of holes, cuts or tears noticed on the product.There was no report of patient harm.No additional information is available at this time.

• Brand Name: 30" (76 CM) APPX 3.9 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK AD
• Common Device Name: CLOSED TRANSFER SYSTEM DEVICE
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 12218143
• Report Number: 9617594-2021-00206
• Device Sequence Number: 4507992
• Product Code: FPA
• UDI-Device Identifier: 00887709095533
• UDI-Public: (01)00887709095533(17)260501(10)5354105
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 05/01/2026
• Device Model Number: CL4130
• Device Catalogue Number: CL4130
• Device Lot Number: 5354105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1