MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP; STOPCOCK, I.V. SET

Catalog Number 011-H3393

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been received for further testing; however, the investigation has not yet begun.As additional information becomes available; a supplemental report will be submitted.

Event Description

It was reported that two hours into a patient infusion of an unknown chemotherapy, there was unprotected chemo exposure to the clinician.The tubing ¿tree¿ was connected to a pump tubing.The priming was performed with physiological serum.A first chemotherapy bag was connected with administration performed without problem.A rinse was then completed.During the rinse, the nurse connected the second chemotherapy bag and she was splashed by the latter because the non-return valve came off or was not stuck.The device was replaced with no further problem encountered.There was no serious injury, no blood loss, no need for medical intervention.There was patient involvement with a 30-minute delay in therapy; however, there was no harm to the patient reported.

Manufacturer Narrative

A used 011-h3393 add-on set was returned with one of the check valves separated at the bond to the trifurcated junction.Examination of the bond interface that separated showed that there was insufficient solvent coverage at the bond interface.Subsequent bond strength testing showed the adjacent check valve bond to no separate and did meet product performance expectations.The probable cause of the bond separation is insufficient solvent coverage during manual assembly at the manufacturer.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information can be found in b5.

Event Description

Additional information received from the reporter stated the therapy was completed.The nurse was in contact with the chemotherapy product without consequence.The drug-infused can be seen on the sample.The chemotherapy product spill was cleaned up according to the installation protocol and no specific kit was used.

• Brand Name: 28 CM (11") ADD-ON SET W/2 CHECK VALVES, VENTED CAP, NON-DEHP
• Type of Device: STOPCOCK, I.V. SET
• 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: 12140106
• MDR Text Key: 260683843
• Report Number: 9617594-2021-00191
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058043
• UDI-Public: (01)00840619058043(17)250601(10)4895914
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3393
• Device Lot Number: 4895914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHYSIOLOGICAL SERUM, UKN MFR; UKN CHEMOTHERAPY, UKN MFR