MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. UNSPECIFIED CLEO SUBQ DISPOSABLE INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Complete Blockage (1094); Fluid/Blood Leak (1250); Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem Erythema (1840)

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event: unknown.No information has been provided to date.D4.Lot number, expiration date, udi, and h4.Manufacture date are unknown; no information has been provided to date.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record could not be completed as no lot number was received.

Event Description

It was reported that the patient¿s pump alarmed, signaling that the remodulin infusion had stopped.To investigate the location of the blockage, the mother checked the needle.She observed that no remodulin was coming out of the needle, so she discarded the remaining cartridge and prepared a new mixture.Upon inspecting the tubing, the mother discovered a piece of loose plastic where the tubing meets the needle.It appeared that there was a stress fracture at that part of the tubing.The patient did not experience any changes in breathing or symptoms, and there was no interruption in therapy.There was patient involvement and patient harm/adverse event reported.There was no medical intervention, and the outcome of the event was resolved.

• Brand Name: UNSPECIFIED CLEO SUBQ DISPOSABLE INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19209766
• MDR Text Key: 341427135
• Report Number: 9617604-2024-00366
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• 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: SQ REMODULIN MS3
• Patient Age: 6 YR