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

Model Number	21-3465-24
Medical Device Problem Code	Flushing Problem (1252)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned; thus the failure mode reported was not confirmed and no root cause could be determined.No lot number was provided; therefore, device history record (dhr) review could not be completed.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 the nurse accessed the port, she was not able to flush the line.A different saline flush was used, but it did not flush.She de-accessed the patient and re-accessed with another port needle and was able to flush.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: 15397426
• Report Number: 3012307300-2022-18454
• Device Sequence Number: 12013749
• Product Code: FPA
• UDI-Device Identifier: 10610586033049
• UDI-Public: 10610586033049
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• 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: 21-3465-24
• Device Catalogue Number: 21-3465-24
• 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: 04/28/2022
• 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