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

Model Number	21-2766-24
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Obstruction of Flow (2423); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.The lot number for this item is not related to the listed recall (rmd-10001296), however, the described issue is similar to the stated recall and therefore this is being reported in accordance with refer to 21 cfr 803 and 21 cfr 806.Cmazalu.
Event or Problem Description
It was reported that during use, a needle was found blocked and a second needle tip was crooked.Photo of product package attached.No patient injury was reported.
Additional Manufacturer Narrative
H10: device evaluation was completed.No product was returned for investigation.Customer attached 1 picture for review.The attached picture shows the packaging pouch, and two base and needle assemblies.The reported occlusion failure mode is not visible from the pictures attached.The needle assembly on top is visible to be bent.The complaint is not confirmed.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• 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): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15088419
• Report Number: 3012307300-2022-14011
• Device Sequence Number: 5161619
• Product Code: FPA
• UDI-Device Identifier: 10610586025594
• UDI-Public: 10610586025594
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 04/16/2026
• Device Model Number: 21-2766-24
• Device Catalogue Number: 21-2766-24
• Device Lot Number: 4125756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown