MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER PLUS LUERACTIV Y-SI; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-2966-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: b3: month and year of event have been provided, day is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that the device needle leaked at the y-port.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
B3: event date added.
Additional Manufacturer Narrative
Device evaluation: one device was returned for investigation.Visual inspection showed no damage or other dysfunctional conditions that could cause the reported failure were observed.Functional testing was performed, no leaks were detected.The reported failure, leaking, was not confirmed.It was not possible to replicate the failure or confirm as manufacturing process caused.After reviewing the mitigations that are performed during the manufacturing process to detect leak, the root cause cannot be determined since the reported failure was not confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No actions taken.
Event or Problem Description
Additional information received confirming the product fault occurred while in patient use.There was no medical intervention.

• Brand Name: DELTEC GRIPPER PLUS LUERACTIV Y-SI
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16722295
• Report Number: 3012307300-2023-03967
• Device Sequence Number: 12754429
• Product Code: FPA
• UDI-Device Identifier: 10610586027741
• UDI-Public: 10610586027741
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2023

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: 21-2966-24
• Device Catalogue Number: 21-2966-24
• Device Lot Number: 4257710
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/29/2023
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 05/12/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 04/20/2023; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2022
• 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