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

Model Number	21-3257-24
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while a nurse tried to remove gripper micro to remove needle after port access but was unable to do so.A second nurse attempted without success so the line was removed and a new needle used to access without issues.Tried to pull back to release gripper after it was removed from patient but still was unsuccessful.No adverse patient effects were reported.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Units received: one unit was received for evaluation; the returned unit was received decontaminated and inside a plastic container which is not its original package.Visual inspection: the units was visually inspected under normal conditions of illumination.Results: it is observed the needles bent.The complaint is confirmed.The most probable root cause is that the product became damaged during use since the units cannot bet inserted in fixture t98-5494 if needle is bent.The cause of the reported problem was traced to the user manipulation of the device during use.No corrective actions are required since it?s unlikely that needle was bent during the manufacturing process.

• 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: 11781488
• Report Number: 3012307300-2021-03891
• Device Sequence Number: 3646043
• Product Code: FPA
• UDI-Device Identifier: 10610586029806
• UDI-Public: 10610586029806
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2023

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 Model Number: 21-3257-24
• Device Catalogue Number: 21-3257-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• 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: 04/05/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 06/14/2023
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 03/07/2022; 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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