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

Model Number	21-2720-24
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle cannot be flushed.No patient injury was reported.
Additional Manufacturer Narrative
The returned samples (5) were received decontaminated; 4 samples were received with its original closed packaging and 1 sample in used condition without its original package.The samples were tested with a syringe to replicate the failure mode.No occlusion was detected.The complaint was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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: 15397563
• Report Number: 3012307300-2022-18491
• Device Sequence Number: 12287740
• Product Code: FPA
• UDI-Device Identifier: 10610586015823
• UDI-Public: 10610586015823
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: 07/07/2025
• Device Model Number: 21-2720-24
• Device Catalogue Number: 21-2720-24
• Device Lot Number: 4006306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• 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: 05/24/2022
• Initial Report FDA Received Date: 09/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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