MAUDE Adverse Event Report: ICU MEDICAL, INC. 14" TRANSFER SET W/4 CLAVE, 2 TRI-CONNECTORS, BACK CHECK VALVE,CLAMP, VENTED CAP; STOPCOCK, I.V. SET

Catalog Number B33973

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2022

Event Type  malfunction  

Event Description

After 2-rn handoff of infusing chemotherapy, i performed a qshift connections check of all tubing connections of active infusions to patient's left upper extremity picc line, double lumen.Purple lumen was infusing methotrexate.Red lumen was infusing sodium bicarbonate.Methotrexate was set up as iv piggyback, with normal saline set up as primary with a 4-port manifold (reference # b33973) spiked to the normal saline bag.The methotrexate bag was connected to one of the ports on the 4-port manifold.The connection to the port was secure, however the attachment of the port to the main stem of the manifold was loose as evidenced by the port spinning freely about the attachment point.No leak was observed.The infusion was paused, tubing clamped, and a second rn was brought in to assess.The connection was deemed insecure.The normal saline bag, primary tubing, and chemolocks were replaced with a new set, without a 4-port manifold.A second defective item was found in the stock while verifying the integrity of the replacement.Item was segregated.Only same lot number available on the floor at the moment.Staff told to be vigilant about verifying connections.Note: there have been additional issues with clave connections.

• Brand Name: 14" TRANSFER SET W/4 CLAVE, 2 TRI-CONNECTORS, BACK CHECK VALVE,CLAMP, VENTED CAP
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 15592527
• MDR Text Key: 301737005
• Report Number: 15592527
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B33973
• Device Lot Number: 5916735
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Sex: Female