MAUDE Adverse Event Report: ST PAUL CADD; ACCESSORIES FLOW STOP

Model Number 21-7336-24

Device Problems Material Puncture/Hole (1504); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Information was received indicating that the cadd administration set - flow stop was broken by the air filter.There were no adverse events reported.

Event Description

Investigation completed on a smiths medical ambulatory infusion pumps|cadd administration sets - flow stop.

Manufacturer Narrative

Corrected data: h6 ( patient code).

• Brand Name: CADD
• Type of Device: ACCESSORIES FLOW STOP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10160988
• MDR Text Key: 195361493
• Report Number: 3012307300-2020-05998
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027291
• UDI-Public: 10610586027291
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7336-24
• Device Catalogue Number: 21-7336-24
• Device Lot Number: 3931548
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1