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

Catalog Number	MX20108
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9616567-2024-00051
• Device Sequence Number: 6807582
• Product Code: FPA
• UDI-Device Identifier: 10351688509772
• UDI-Public: (01)10351688509772
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MX20108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GANCICLOVIR; MYCOPHENYLATE
• Patient Sex: Unknown