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	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is unable to flush through the needle due to high pressure resistance.No patient injury was reported.
Additional Manufacturer Narrative
One unit was received for evaluation; the returned unit was received decontaminated without its original packaging.Functional testing: one unit was tested for occlusion by introducing water with a syringe.The unit is occluded in the y connector, it is observed blood.The complaint is confirmed.As part of the standard process, production personnel perform a 100% occlusion test; the operator use the following matrix for correct interpretation of test result.The disposition of all the units that failed the occlusion test, is to make the product unusable cutting at the tube to base bond and scrap it putting into the appropriate reject bin to avoid mix-up with the acceptable units.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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: 15405640
• Report Number: 3012307300-2022-18777
• Device Sequence Number: 5640684
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2022

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: 09/20/2025
• Device Model Number: 21-3468-24
• Device Catalogue Number: 21-3468-24
• Device Lot Number: 4042801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• 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