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

Model Number	21-2714-24
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Operator of device is unknown.No information has been provided to date.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.No discrepancies were detected.The root cause of the reported issue was not found, no anomalies were found in the samples received.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
Event or Problem Description
It was reported that when inserting the needle into the port-a-cath the needle bent.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: 15403339
• Report Number: 3012307300-2022-18754
• Device Sequence Number: 5006466
• Product Code: FPA
• UDI-Device Identifier: 10610586015786
• UDI-Public: 10610586015786
• 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: Foreign,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
• Device Model Number: 21-2714-24
• Device Catalogue Number: 21-2714-24
• Device Lot Number: 36X147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• 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
• 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