MAUDE Adverse Event Report: ST PAUL DELTEC; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2715-24
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle seemed soft and slightly bent at the side.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.Additionally, operations were reviewed.No discrepancies were found.Product samples were received for evaluation.Visual inspection and functional testing were performed.No discrepancies were detected and no anomalies were found that could affect the product functionality.No root cause has been determined since no anomalies were found in the samples received for evaluation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: DELTEC
• 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: 15402915
• Report Number: 3012307300-2022-18746
• Device Sequence Number: 5056376
• Product Code: FPA
• UDI-Device Identifier: 10610586015793
• UDI-Public: 10610586015793
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2022

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: 11/01/2022
• Device Model Number: 21-2715-24
• Device Catalogue Number: 21-2715-24
• Device Lot Number: 37X1452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• 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: 07/21/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2017
• 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