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

Model Number 21-7062-24

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: one cadd extension set was returned for investigation in used condition.The sample was visually inspected at a distance of 12 to 24 inches and normal conditions of illumination.  a cut was found in the tube.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The investigator concluded that the cut in the tubing most likely occurred after the product left the manufacturing facility.The investigator noted that it was highly unlikely that the tubing was cut during the manufacturing process.The problem source of the reported product problem was unknown.A true root cause was not established.

Event Description

It was reported that the extention line on the cadd extension set was severed.The patient went to hospice care with this product problem.No patient injury or complications were reported in relation to this event.

• Brand Name: CADD EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 3350 granada avenue north; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9968019
• MDR Text Key: 187920418
• Report Number: 3012307300-2020-03171
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020452
• UDI-Public: 10610586020452
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K942046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7062-24
• Device Catalogue Number: 21-7062-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1