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

Model Number	21-3468-24
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) unit was received decontaminated without its original packaging.The unit was tested by introducing water with a syringe in order to verify for air in line.No air was detected and the water flowed without any problems.The complaint was not confirmed; thus, no root cause could be determined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
Event or Problem Description
It was reported that, when the nurse accessed the port for lab draw, the nurse was unable to aspirate blood and only a small amount was obtained with a syringe full of air.The patient was re-accessed with a new needle.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: 15397415
• Report Number: 3012307300-2022-18448
• Device Sequence Number: 17395149
• Product Code: FPA
• UDI-Device Identifier: 10610586033070
• UDI-Public: 10610586033070
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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 Expiration Date: 11/14/2025
• Device Model Number: 21-3468-24
• Device Catalogue Number: 21-3468-24
• Device Lot Number: 4068063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• 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): Yes
• Date Device Manufactured: 11/30/2020
• 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