MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX CONTRAST ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MX20108

Device Problem Disconnection (1171)

Patient Problem Chemical Exposure (2570)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

D4: lot number, full udi, expiration date and h4: manufacture date are unknown; no information has been provided to date.H3: other; device not returned to manufacturer.Device evaluation: no product was returned, and analysis was conducted using customer provided photos.It was observed that the product shown on the pictures are not manufactured by icu medical as the pictures were compared with the drawing of reported part number.A device history record (dhr) review could not be performed as the lot number was unknown.Awareness was given to personnel who perform the assembly process of the reported part number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

Event Description

It was reported that they have had multiple incidents of the needleless connectors falling out when they¿re supposed to be bonded on.The 8-port manifold was infusing mycophenylate (hazardous drug) when another manifold port with used tubing for ganciclovir (also hazardous) disconnected below needleless connector.They have been seeing and reporting the same defect.This caused a hazardous medication spill of mycophenylate ~100 ml.Inherent hazardous drug exposure risk to staff, patient, others, and infection risk from open tubing.Caused interruption of vital iv therapies waste/cost of replacement therapies and tubing.There was known patient involvement and patient harm.Product will not be returned due to hazardous drug spill.Adverse patient effects and treatment were not provided.

• Brand Name: MEDEX CONTRAST ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18975045
• MDR Text Key: 338550819
• Report Number: 9616567-2024-00051
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10351688509772
• UDI-Public: (01)10351688509772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX20108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GANCICLOVIR; MYCOPHENYLATE