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

Lot Number 4334412

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Spoke with iv remodulin pt who spontaneously reported her cadd extension set is currently leaking.Pt reports that the filter has a tiny hole, and her medication is leaking out.Pt reports this is the second time that this has occurred with this batch of tubing.Pt reported that it leaked about 8 days ago, as well, but pt did not call in to report at that time, as she thought it was user error (pt now believes it is a product issue).She switched tubing at that time and did not experience any interruption in therapy.Pt provided lot number 4334412 as the affected lot.Pharmacist confirmed that pt is switching tubing now and has non-affected tubing to switch to.Pt confirmed.Pt reports no interruption in therapy.Pt denies issues or malfunction with pumps or cassettes.We set up tubing order to ship for tomorrow, (b)(6) 2023.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Did we replace device? yes.Did the patient have a backup device they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved? ongoing? resolved.Reported to cvs/caremark by: patient/caregiver.Reference report: mw5118861.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17217127
• MDR Text Key: 318139050
• Report Number: MW5118862
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4334412
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: PUMP.; REMODULIN.
• Patient Sex: Female