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

Model Number	21-3466-24
Medical Device Problem Codes	Flushing Problem (1252); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the nurse attempted to access the patient's port, the patient grimaced.The needle was unable to be flushed or draw and when the needle was withdrawn a small distance, it would flush but not draw.It was reported that the needle felt rough instead of smooth; and felt like there was a burr on the edge.A new needle was used and the port was accessed without any incident.No patient injury was reported.
Additional Manufacturer Narrative
Lot number: there were 2 lot numbers reported because the nurse was not certain from which lot the needle was pulled.The reporter referenced medwatch #4400480000-2019-8028, to report this event.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 conducted for both lot numbers reported, which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• 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: 15397565
• Report Number: 3012307300-2022-18492
• Device Sequence Number: 6102637
• Product Code: FPA
• UDI-Device Identifier: 10610586033056
• UDI-Public: 10610586033056
• 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: User Facility
• 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 Expiration Date: 09/09/2024
• Device Model Number: 21-3466-24
• Device Catalogue Number: 21-3466-24
• Device Lot Number: 3865519 OR 3854215
• 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: 04/29/2022
• Initial Report FDA Received Date: 09/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2019
• 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