MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7323-24
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.
Event or Problem Description
It was reported that tygacil cadd did not empty completely, with about half of the drug remaining.Picc line was positional and had sluggish blood return.Tpa used for white and pink lumens.Only pink lumen was positive for br at end of visit.Midlevel made aware.Pump was serviced.No patient injury was reported.
Additional Manufacturer Narrative
Other text: additional information was received indicating patient details.Updated a2, a3, a4, a5, a6, corrected data: d4: model # should be null.
Additional Manufacturer Narrative
Other text: h6: event problem and evaluation codes: updates not required.H10: the device was not returned for investigation, so no visual inspection and functional test were performed.Based on the fact that no product was returned, the investigator was unable to confirm the reported complaint.A dhr (device history review) was performed, and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: CADD
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14320687
• Report Number: 3012307300-2022-08044
• Device Sequence Number: 4586786
• Product Code: FPA
• UDI-Device Identifier: 10610586039614
• UDI-Public: 10610586039614
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2022

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 Model Number: 21-7323-24
• Device Catalogue Number: 21-7323-24
• Device Lot Number: 4222371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 04/29/2022; 11/18/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/19/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White