MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-2863-24

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that when priming the product during the pre-use check, he felt an unusual resistance through it and was unable to advance the syringe.No patient injury was reported.

Manufacturer Narrative

Other text: h6: health impact and evaluation codes: updated.H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found no damage can be observed on the base and needle.Functional testing found occlusion was observed between the tube and needle base.The complaint is confirmed.The root cause of the reported issue was found to be manufacturing - excess solvent.Awareness notification was made to production personnel in order to explain the importance to adherence or following in the procedure ".Gripper huber needle luer bonding assembly.Section 5.0 solvent bond tube to luer by quality engineer on november 04, 2022.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC GRIPPER PLUS NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15258676
• MDR Text Key: 298225874
• Report Number: 3012307300-2022-15657
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586025679
• UDI-Public: 10610586025679
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2863-24
• Device Catalogue Number: 21-2863-24
• Device Lot Number: 4232500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1