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

Lot Number 4163598

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

Patient reported cadd ext set tubing malfunction (lot number 4163598).She noticed that for one set, the threads on the tubing were shot and resulted in her tubing disconnecting.She said it seems like the tubing from this lot number has threads that won't stay secure and keeps coming disconnected.And today, she had to change her tubing because suddenly she felt wet and when she looked to see what was going on, her tubing was almost broken in half/ripped.All problematic tubing is from lot number 4163598.Advised that we will have tubing of a different lot number sent.Unknown how many extension sets patient has from this lot.No other information known.Did the pt have a backup device they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes.What is the outcome of the event? resolved.Sending replacement tubing of different lot.Did the reported product fault occur while in use with a pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual device is available to be returned for investigation? yes, as long as pt retains it.Did we mfr replace the device? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13282700
• MDR Text Key: 284117731
• Report Number: MW5106696
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4163598
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female