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

Model Number	21-2947-24
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that on the third day of an infusion, the patient felt a leak in the infusion, and saw that the extension tube was broken, the nurse turned off the infusion in time and removed the needle, and replaced it with a new needle to continue the infusion.No patient injury was reported.
Additional Manufacturer Narrative
Other text: h6 conclusion codes: updated.Device evaluation: one device and one photo was submitted for investigation.The unit was observed to have the tubing between the y-site and base broken in two pieces.The damage to the tubing does not present any stress marks, the damage resembles being cut clean with a sharp instrument.Evidently the damage will cause the unit to leak, the reported failure is confirmed.The root cause is the product became damaged after it left the manufacturing facilities.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 corrective actions taken.

• 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: 16755749
• Report Number: 3012307300-2023-04223
• Device Sequence Number: 8528783
• Product Code: FPA
• UDI-Device Identifier: 10610586016776
• UDI-Public: 10610586016776
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,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: 21-2947-24
• Device Catalogue Number: 21-2947-24
• Device Lot Number: 4257771
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/03/2023
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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