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

Model Number	21-2861-24
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon de-access of the needle, it was found to be twisted.No patient injury was reported.
Additional Manufacturer Narrative
No product was returned for evaluation.Four (4) pictures were received which showed the needle twisted as reported in the complaint and the product traceability from its label.The most probable root cause is that the product became damaged after it left the facility since a poka-yoke fixture exists ensuring this defect does not leave the manufacturing site.A device history record (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC GRIPPER PLUS SAFETY NEEDLES
• 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; minneapolis, MN 55442
• MDR Report Key: 15397872
• Report Number: 3012307300-2022-18556
• Device Sequence Number: 12287744
• Product Code: FPA
• UDI-Device Identifier: 10610586025655
• UDI-Public: 10610586025655
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2022

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: 12/21/2024
• Device Model Number: 21-2861-24
• Device Catalogue Number: 21-2861-24
• Device Lot Number: 3922529
• 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: 05/24/2022
• Initial Report FDA Received Date: 09/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• 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