MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXT SET; PUMP, INFUSION

Device Problems Disconnection (1171); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2020

Event Type  malfunction  

Event Description

Pt's husband spontaneously called to report that some of the tubing twists up and disconnects.He stated that it is not secured / tight and it takes 2-3 times to connect correctly.He does not have lot number because the box was discarded.Advised that pharmacy will ship more tubing and to call the pharmacy with lot number if it happens again.Pt had different tubing set to switch to and continue his life sustaining infusion.Pharmacy shipped more tubing.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.Did the reported product fault occur while in use with a pt? no.Did the product issue cause or contribute to pt or clinical injury? no.Is the actual device available for investigation? unk.Did we (mfr) replace device? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXT SET
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 9659258
• MDR Text Key: 177674288
• Report Number: MW5092701
• Device Sequence Number: 1
• Product Code: FRN
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 19 YR