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

Model Number	21-2762-24
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was not continuous and completely locked.No patient injury was reported.
Additional Manufacturer Narrative
One unit was received decontaminated without its original packaging.It was tested for occlusion by introducing water with a syringe.The unit sample was found occluded; the failure mode reported is confirmed.The root cause is excess solvent in the component bonding operation.Awareness notification was made to production personnel for the occlusion failure mode.A device history record (dhr) review indicated 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 SAFETY NEEDLES
• 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: 15397567
• Report Number: 3012307300-2022-18494
• Device Sequence Number: 17667940
• Product Code: FPA
• UDI-Device Identifier: 10610586025556
• UDI-Public: 10610586025556
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/10/2022

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: 09/08/2025
• Device Model Number: 21-2762-24
• Device Catalogue Number: 21-2762-24
• Device Lot Number: 4037332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• 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): Yes
• Date Device Manufactured: 09/21/2020
• 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