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

Model Number	21-3367-24
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
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 photo was received for evaluation.Review of the photo confirmed the reported event.A review of the manufacturing process was performed.No discrepancies were detected during visual inspection.Production performs 100% visual inspection to assure that the bases are free of damage such as bent needle.No discrepancies were found during the inspection test.The most probable root cause is that the product became damaged after it left the facility.All mitigations on placed were verified and it was confirmed that it has been executing according, therefore no corrective actions could be implemented, this failure will continue to be monitor in this product for threshold or escalation.Production personnel was notified by the quality engineer as awareness of the defect reported by the customer.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that the infusion needle was crooked when inserted and fell off when pulled out.No patient injury was reported.

• 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: 15354226
• Report Number: 3012307300-2022-17777
• Device Sequence Number: 20402596
• Product Code: FPA
• UDI-Device Identifier: 10610586033001
• UDI-Public: 10610586033001
• Combination Product (Y/N): N
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2022

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
• Device Expiration Date: 02/05/2025
• Device Model Number: 21-3367-24
• Device Catalogue Number: 21-3367-24
• Device Lot Number: 3941625
• 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: 04/21/2022
• Initial Report FDA Received Date: 09/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• 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