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

Model Number	21-7062-24
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9968019
• Report Number: 3012307300-2020-03171
• Device Sequence Number: 14377617
• Product Code: FPA
• UDI-Device Identifier: 10610586020452
• UDI-Public: 10610586020452
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1