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

Model Number	21-2766-24
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) sample was received in used condition without its original packaging.The sample was visually inspected at a distance of 12 inches to 24 inches and normal conditions of illumination.No discrepancies were detected in the sample.The sample was tested with a syringe to replicate the failure mode.Occlusion was detected in the bond between the tube and luer.The occurrence for this failure - clamp to tube and luer bonding - could be caused by: operator error and incorrect solvent dispenser.All mitigations in place were verified and confirmed that they have been executed accordingly; therefore no corrective actions could be implemented.Monitoring of this failure condition will be continued for threshold or escalation.A device history record (dhr) review was not performed as no lot or serial numbers were provided.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, after connecting the product to a solution administration set, when the customer was priming, he noticed that the medical fluid could not pass through the product successfully.No patient injury was reported.

• 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; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15397420
• Report Number: 3012307300-2022-18451
• Device Sequence Number: 12013747
• Product Code: FPA
• UDI-Device Identifier: 10610586025594
• UDI-Public: 10610586025594
• 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: 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 Model Number: 21-2766-24
• Device Catalogue Number: 21-2766-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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