MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS POWER P.A.C. SAFETY HUBER NEE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-3362-24
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned, thus the failure mode reported could not be investigated and a root cause could not be determined.A device history record (dhr) review was not performed as no lot or serial numbers were provided.If the product is returned, this complaint will be reopened for further investigation.This remediation mdr was generated under protocol (b)(4)., as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that, when they injected through the power port tubing the pressure would rise up; but at 300 psi, it would be considered pressure limiting and the injector itself will suddenly drop the rate - not gradually but quickly, at 1 or 2 ml per second, which can cause a nonoptimal enhancement of the contrast.No patient injury was reported.

• Brand Name: DELTEC GRIPPER PLUS POWER P.A.C. SAFETY HUBER NEE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15397428
• Report Number: 3012307300-2022-18459
• Device Sequence Number: 5007314
• Product Code: FPA
• UDI-Device Identifier: 10610586032967
• UDI-Public: 10610586032967
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: 21-3362-24
• Device Catalogue Number: 21-3362-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown