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

Model Number	21-2948-24
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned, thus the failure mode reported could not be investigated and a root cause could not be determined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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 needle bent diagonally when it was inserted into the port septum, making it unusable.Another needle from a different lot was used with no issues.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: 15397573
• Report Number: 3012307300-2022-18499
• Device Sequence Number: 20359091
• Product Code: FPA
• UDI-Device Identifier: 10610586016783
• UDI-Public: 10610586016783
• 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: Administrator/Supervisor
• 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: 07/18/2024
• Device Model Number: 21-2948-24
• Device Catalogue Number: 21-2948-24
• Device Lot Number: 3841589
• 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: 04/29/2022
• Initial Report FDA Received Date: 09/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• 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