MAUDE Adverse Event Report: ST PAUL REMOTE RESERVOIR ADAPTER CASSETTE WITH BAG SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7022-24

Device Problems Restricted Flow rate (1248); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that on (b)(6) the technician had to use a syringe from bag into the tubing; solution not running freely.Experienced with 5 patients during 2 day period.No injury reported.

Manufacturer Narrative

Evaluation: nineteen returned samples were received in unused conditions.No damages or other defects were detected on the samples.Functional tests: results: no discrepancies were detected on the samples, the test successfully passed with a result within specification; thus, the failure mode reported is not confirmed.Other analysis was not required since delivery accuracy test successfully passed.Root cause cannot be determined since complaint was not confirmed.Action taken is not required since complaint was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: REMOTE RESERVOIR ADAPTER CASSETTE WITH BAG SPIKE
• Type of Device: 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: 16418242
• MDR Text Key: 309983130
• Report Number: 3012307300-2023-01544
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586019791
• UDI-Public: 10610586019791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7022-24
• Device Catalogue Number: 21-7022-24
• Device Lot Number: 4349215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Black Or African American