MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SA; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2733-24
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unit was received for evaluation; the returned unit was received decontaminated without its original packaging.The unit was tested for occlusion by introducing water with a syringe and found occlusion between the tube and luer.The failure mode reported is confirmed.As part of the standard process, production personnel perform a 100% visual inspection on the base for excess solvent and delamination.The root cause is excess solvent in the component bonding operation.Awareness notification was made to production personnel for the occlusion failure mode.Device history record (dhr) review relevant to the lot reported found no discrepancies or anomalies during manufacturing.This remediation mdr was generated under protocol (b)(4)., as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the line would not prime past the top of the line/needle as if there is a blockage.No patient injury was reported.

• Brand Name: DELTEC GRIPPER MICRO BLUNT CANNULA, NON-CORING SA
• 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: 15397419
• Report Number: 3012307300-2022-18452
• Device Sequence Number: 5007310
• Product Code: FPA
• UDI-Device Identifier: 10610586015847
• UDI-Public: 10610586015847
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• 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: 10/15/2023
• Device Model Number: 21-2733-24
• Device Catalogue Number: 21-2733-24
• Device Lot Number: 3716085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2018
• 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