MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/15/2024

Event Type  Injury  

Event Description

Per cnss communication: "pt called cnss (b)(6) 2024 to report line issue.Pt left home to go to work at 0900, at the time she called, & noticed her shirt was covered in blood & that the extension tubing broke off from the invision cap.She turned off her pump & immediately drove home.We had a teleconference, the pt never did clamp her central line when she noted the event, hence the back flow of blood.Pt then clamped her line.Central line dressing remained dry & intact.Afterwards there were clots noted at the central line end.Pt donned sterile gloves & started cleaning the central line end point to the best of her ability; she was able to remove several clots.She then replaced her invision cap & mixed another cassette & primed another extension tubing.So far, a few minutes after the infusion was restarted, there seems to have not been any issue.Dr.(b)(6) was made aware & asked if the pt needed to go to the er.Iv remodulin pt.Did the reported product fault occur while in use with the pt? yes.Did the product issue cause or contribute to pt or clinical injury? yes (blood); no medical intervention required.Is the actual product available for investigation? unknown.Per md as long as the infusion is working & that she has no signs and symptoms of infection, pt is ok.Relayed info with the pt & went over signs & symptoms of central line infection.Pt is agreeable to treatment plan & is aware to reach out for any other issues or concerns.Adverse event start date: 02/15/2024.Adverse event resolution date: 02/15/2024.Description of event: end of the invision cap broke off with the extension tubing.Side effects: extension tubing broke off from the invision cap.No further info, detail, or date, available.Lot numbers & expiration date, of invision cap and cadd ext.Set is unknown.It is unknown if the defective products are available for return.Reported to (b)(6) by: health professional.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 18799386
• MDR Text Key: 336559517
• Report Number: MW5152088
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ADEMPAS. ; IV CONNECT INV PLUS TOUCH S.; REMODULIN MDV.
• Patient Age: 54 YR
• Patient Sex: Female