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

Lot Number 4091449

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous.Pt reports 4 of her cadd extension sets leaked around the filter area; date not provided.Lot number 4091449, expiration date 01/04/2026.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? yes; did we replace [mfr] the device? yes; did the pt have a backup they were able to switch to? yes; was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXTENSION SET TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12662636
• MDR Text Key: 277680694
• Report Number: MW5104754
• 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
• Type of Report: Initial
• Report Date: 05/07/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 4091449
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1