MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	21-2770-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-use flush there was an absence of fluid that passed through the device.No patient injury or involvement was reported.
Additional Manufacturer Narrative
One sample received at the investigation site in used conditions without its original packaging.The sample was visually inspected at a distance of 12 inches under normal lighting in order to detect any damage on the unit.Functional testing revealed that an occlusion was detected in the sample, in the bond between the tube and the base.The root cause was related to the manufacturing process.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.D5 was unknown.No information has been received to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: DELTEC GRIPPER PLUS NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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; 4-1-5, izumi-chuo, izumi-ku,; minneapolis, MN 55442
• MDR Report Key: 15417167
• Report Number: 3012307300-2022-19079
• Device Sequence Number: 2544862
• Product Code: FMI
• UDI-Device Identifier: 10610586025631
• UDI-Public: 10610586025631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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
• Device Expiration Date: 09/14/2024
• Device Model Number: 21-2770-24
• Device Catalogue Number: 21-2770-24
• Device Lot Number: 3866522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• 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: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2019
• 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